Removable deployment device, system, and method for implantable prostheses

ABSTRACT

A prosthesis includes an enclosure. A flexible support structure is situated at least partially within the enclosure and is removable therefrom. The flexible support structure occupies a total circumferential area and has a stiffness that is sufficient to allow the prosthesis to assume a deployed (e.g., generally planar) configuration. A tab is adjoined with the flexible support structure and extends external to the enclosure. Pulling the tab directionally away from the prosthesis causes a reconfiguration of the flexible support structure sufficient to enable the flexible support structure to pass through an opening in the prosthesis having a total circumferential area that is less than the total circumferential area occupied by the flexible support structure when the prosthesis is in the deployed (e.g., generally planar) configuration, enabling removal of the flexible support structure from the enclosure.

RELATED APPLICATION

This application claims priority to, and the benefit of, co-pending U.S.Provisional Application No. 61/616,150, filed Mar. 27, 2012, for allsubject matter common to both applications. The disclosure of saidprovisional application is hereby incorporated by reference in itsentirety.

FIELD OF THE INVENTION

The present invention relates to deployment devices, systems, andmethods suitable for medical applications, such as open and laparoscopicventral hernia repairs and small hernia repair (e.g., repair ofumbilical or epigastric defects). More particularly, the presentinvention relates to a removable deployment device configured to fitwithin an enclosure of a prosthesis and serve as a surgical aid in thedeployment, positioning, and fixation of the prosthesis.

BACKGROUND OF THE INVENTION

Prostheses often are implanted during surgical or other medicalprocedures to aid in repair of defects, reinforcement of a target site,delivery of therapeutic, or to serve other medical purposes. Forexample, hernia patches or other similar prostheses are commonlyimplanted using open or laparoscopic techniques. Such techniques can beuseful in treating central hernias as well as small hernias, e.g.,umbilical or epigastral defects.

For instance, open procedures are performed by making a single incisionthrough which a hernia patch is inserted for implantation to the targetsite. Typically, the hernia patch is rolled up or otherwise compactedprior to insertion so as to enable greater ease of passage through thesingle incision and to the site of the defect. Once the hernia patch isappropriately positioned within the body (e.g., in the abdominal cavity,in the pre-peritoneal space, etc.), it can be unfolded, unrolled,un-collapsed, or otherwise caused to assume a deployed, generally planarconfiguration.

However, deploying the hernia patch in this manner is a cumbersome taskthat requires skillful manual manipulation. Even then, it is oftendifficult for an adept surgeon given that such a task is performed underseveral layers of tissue. Furthermore, manipulation of the hernia patchcan prove to be an even greater challenge in the case of laparoscopicprocedures, since trocars used to implant the hernia patch providelimited range of motion, thereby requiring the surgeon to utilize smallinstruments and graspers.

Several existing mesh patches provide a base layer of mesh with secondor third layers that form pockets, aprons, or other enclosures intendedto aid in the manipulation and fixation of the mesh. Furthermore, amongthese, some mesh patches include a rigidified perimeter and/or a rigidring or frame attached near a perimeter of the patch to cause the patchto assume a deployed, generally planar configuration once inserted intoa patient. In some instances, the ring or frame is constructed frombiodegradable material that can be absorbed over time. These absorbablerings or frames tend to lack sufficient strength or can potentiallyinterfere with the intended functionality of the patch, e.g., tissuein-growth or reinforcement. In other instances, the ring or frame isformed of non-absorbable material (e.g., polypropylene, PTFE, etc.) andthus remains a permanent structure within the body. These patches tendto exhibit greater strength, but consequently may interfere with thefunctionality of the patch. For example, permanent rings can formadditional contours that can create points of tension at particularlyundesirable positions on the surface of the patch. Still other attemptsto facilitate deployment provide a monofilament or wire ring that iscrimped or sintered in order to adjoin the ends, which create yetadditional weak points that historically have been associated withhigher risk of failure, health complications, and even death afterimplantation.

SUMMARY

There is a need for a deployment device capable of providing suitablestructural reinforcement to deploy a patch or other prosthesis, withoutsacrificing performance of the patch or prosthesis due to prolonged orpermanent occupancy in a body. There is also a need for a deploymentdevice that results in less foreign material being permanently implantedin the patient. The present invention is directed toward furthersolutions to address this and other needs, in addition to having otherdesirable characteristics that will be appreciated by one of skill inthe art upon reading the present specification.

In accordance with an example embodiment of the present invention, adeployment device includes a flexible support structure configured ingenerally planar form having a total circumferential area in a deployedconfiguration, and configured to independently apply a radial deploymentforce to achieve the deployed configuration. A separation line in theflexible support structure extends in a generally serpentine shape froma central portion of the flexible support structure to a perimeter ofthe flexible support structure. A through-cut is disposed at and aninnermost end of the separation line at the central portion of theflexible support structure. A first strap is coupled with the flexiblesupport structure in the central portion and proximal the through-cut. Asecond strap is coupled with the flexible support structure in thecentral portion and more distal from the through-cut than the firststrap. A pulling force applied to the first strap can initiateseparation along the separation line beginning at the through-cut. Thesecond strap is configured and positioned in such a way that a pullingforce applied to the second strap does not initiate separation along theseparation line beginning at the through-cut, thereby making the secondstrap a useful positioning tool for positioning the flexible supportstructure.

In accordance with aspects of the present invention, the flexiblesupport structure can be configured to be removed through an opening ina prosthesis having a total circumferential area that is less than thetotal circumferential area occupied by the flexible support structurewhen in the deployed configuration. The deployment device can includethe separation line, and the deployment device further can furtherinclude a removable connector piece coupling the portions of theflexible support structure across the separation line. An additionalstrap can be coupled to the removable connector piece for removing theremovable connector piece.

In accordance with aspects of the present invention, the deploymentdevice can include the separation line, wherein the separation lineincludes a plurality of through-holes or a continuous strip of material.The deployment device can include the separation line in the flexiblesupport structure. The separation line can include an inner portionhaving a first thickness and an outer portion having a second thickness,the first thickness being greater than the second thickness.

In accordance with aspects of the present invention, the first strap andthe second strap can be coupled together at ends proximal the flexiblesupport structure. The first strap and the second strap can be acontinuous elongate strap. The first strap and the second strap can beadapted to lock together at ends distal from the flexible supportstructure forming a positioning tool suitable for positioning thedevice. The first strap and the second strap can be adapted to locktogether at locations distal from the flexible support structure, andwhen in a locked configuration form a positioning tool for positioningthe device, and when in an unlocked configuration form a removal toolenable the pulling force applied to the first strap to initiate theseparation along the separation line beginning at the through-cut.

In accordance with aspects of the present invention, the totalcircumferential area of the flexible support structure configured ingenerally planar form in the deployed configuration can be sized anddimensioned to fit within and completely expand and deploy a prosthesisinto which the device is positioned, the prosthesis comprising a toplayer and a bottom layer coupled together and forming an enclosuretherebetween into which the device is configured for placement.Separation along the separation line can terminate at a ringconfiguration formed by the outer perimeter of the flexible supportstructure. A reinforcing lip can be disposed along the separation line.

In accordance with an embodiment of the present invention, a systemincludes a prosthesis comprising a top layer and a bottom layer coupledtogether and forming an enclosure therebetween, the top layer having anaperture opening to the enclosure, wherein a circumferential area of theaperture is less than a circumferential area of the top layer in whichthe aperture is disposed. A deployment device is removably disposedwithin the enclosure. The deployment device includes a flexible supportstructure configured in generally planar form having a totalcircumferential area in a deployed configuration, and configured toindependently apply a radial deployment force to achieve the deployedconfiguration when positioned within the enclosure of the prosthesis. Aseparation line in the flexible support structure extends in a generallyserpentine shape from a central portion of the flexible supportstructure to a perimeter of the flexible support structure. A firststrap coupled with the flexible support structure in the central portionextends through the aperture and external to the prosthesis. A secondstrap coupled with the flexible support structure in the central portionextends through the aperture and external to the prosthesis. A pullingforce applied to the first strap can initiate separation along theseparation line. The second strap can be positioned in such a way that apulling force applied to the second strap does not initiate separationalong the separation line. Wherein if a pulling force is applied to thefirst strap, separation occurs along the separation line the flexiblesupport structure reconfigures from the generally planar form to anelongate continuous strip and continued pulling force causes theelongate continuous strip to pass through the aperture in such a waythat the flexible support structure is ultimately removed from theprosthesis.

In accordance with aspects of the present invention, a through-cut canbe disposed at and an innermost end of the separation line at thecentral portion of the flexible support structure. The first strap canbe disposed proximal the through-cut. The second strap can be disposedmore distal from the through-cut than the first strap.

In accordance with aspects of the present invention, portions of theflexible support structure along the separation line can be coupledtogether prior to removal and are configured to separate for removal ofthe deployment device from the prosthesis. The deployment device caninclude the separation line, and the separation line can include aplurality of through-holes or a continuous strip of material. Thedeployment device further can include a stress relief hole or openingsituated in and through the flexible support structure proximate to aninner end of the separation line.

In accordance with aspects of the present invention, the separation linecan include an inner portion having a first thickness and an outerportion having a second thickness, the first thickness being greaterthan the second thickness. The first strap and the second strap can beadapted to assume a locked configuration forming a positioning tool andan unlocked configuration forming a deployment device removal tool. Thefirst strap and the second strap can be coupled together at endsproximal the flexible support structure. The first strap and the secondstrap can be a continuous elongate strap.

In accordance with aspects of the present invention, the flexiblesupport structure can have an elasticity that generates a forcesufficient to cause the prosthesis to assume a deployed configurationfrom a non-deployed configuration. The total circumferential area of theflexible support structure configured in generally planar form in thedeployed configuration can be sized and dimensioned in such a way thatthe structure fits within and completely expands and deploys theprosthesis. Separation along the separation line can terminate at a ringconfiguration formed by the outer perimeter of the flexible supportstructure. A reinforcing lip can be disposed along the separation line.

In accordance with an embodiment of the present invention, a kitincludes a prosthesis comprising a top layer and a bottom layer coupledtogether and forming an enclosure therebetween, the top layer having anaperture opening to the enclosure, wherein a circumferential area of theaperture is less than a circumferential area of the top layer in whichthe aperture is disposed. A deployment device provided in the kit caninclude a flexible support structure configured in generally planar formhaving a total circumferential area in a deployed configuration, andconfigured to independently apply a radial deployment force to achievethe deployed configuration when positioned within the enclosure of theprosthesis. A separation line in the flexible support structure extendsin a generally serpentine shape from a central portion of the flexiblesupport structure to a perimeter of the flexible support structure. Afirst strap couples with the flexible support structure in the centralportion. A second strap couples with the flexible support structure inthe central portion. A pulling force applied to the first strapinitiates separation along the separation line. The second strap can bepositioned in such a way that a pulling force applied to the secondstrap does not initiate separation along the separation line. If apulling force is applied to the first strap, separation can occur alongthe separation line the flexible support structure reconfigures from thegenerally planar form to an elongate continuous strip capable of passingthrough the aperture of the prosthesis.

In accordance with an example embodiment of the present invention, aprosthesis can be diagrammatically parsable into first, second, third,and fourth quadrants having substantially equal areas. The prosthesiscan include an enclosure extending substantially to a perimeter of theprosthesis at least once in at least two of the first, second, third,and fourth quadrants. A flexible support structure can be removablydisposed at least partially within the enclosure and can occupy a totalcircumferential area. The flexible support structure can have anelasticity that generates a force sufficient to cause the prosthesis toassume a deployed configuration from a non-deployed configuration. A tabcan be adjoined with the flexible support structure and extendingexternal to the enclosure. The flexible support structure can beconfigured in such a way that pulling the tab directionally away fromthe prosthesis causes a reconfiguration of the flexible supportstructure sufficient to enable the flexible support structure to passthrough an opening in the prosthesis having a total circumferential areathat is less than the total circumferential area occupied by theflexible support structure when the prosthesis is in the deployedconfiguration, thereby enabling removal of the flexible supportstructure from the enclosure.

In accordance with aspects of the present invention, the flexiblesupport structure can include at least one flexible sheet member. Theflexible sheet member can include two or more portions that do or do notoverlap in a deployed state, depending on the embodiment. The flexiblesupport structure can include a flexible sheet member having one or moreslits or openings disposed therethrough. The one or more slits oropenings can enable the flexible support structure to reconfigure duringremoval of the flexible support structure into a different shape havinga peripheral edge that delineates a reduced effective diameter. Thereconfiguration of the flexible support structure during removal of theflexible support structure can result in at least one of a reducedlength of the flexible support structure, a reduced width of theflexible support structure, or a reduced effective diameter of theflexible support structure. The flexible support structure can be aflexible framework. The flexible support structure can be configured toapply a generally radially outward force on a radially outermost surfaceof the enclosure.

In accordance with aspects of the present invention, the tab can extendthrough the opening in the prosthesis. The opening in the prosthesisfurther can be disposed in and through a layer or surface of theprosthesis, in such a way that the central opening provides access tothe enclosure. The opening in the prosthesis can be an outer openingdisposed in and completely through the outer surface of the enclosure.The tab can extend through the outer opening in the outer surface of theenclosure. The tab can include one or more elongate straps.

In accordance with aspects of the present invention, the flexiblesupport structure further can include a separation line extending in agenerally serpentine shape from a central portion of the flexiblesupport structure to a perimeter of the flexible support structure. Theserpentine separation line can follow along a continuous strip ofmaterial. The serpentine separation line can include a plurality ofthrough-holes. The flexible support structure further can include astress relief hole situated at an inner end of the separation line. Thetab can include one or more straps, and the flexible support structurefurther can include two or more slots for receiving the one or morestraps.

An edge can extend in a generally serpentine shape from a centralportion of the flexible support structure to a perimeter of the flexiblesupport structure. A removable connector piece can be coupled to theflexible support structure, and the removable connector piece cansecurely connect portions of the flexible support structure abuttingalong the edge to each other. The removable connector piece can includea central portion and one or more elongate portions coupled to thecentral portion, and the flexible support structure further can includea plurality of slits for receiving the one or more elongate portions.The tab can include one or more straps, and the flexible supportstructure further can include two or more slots for receiving the one ormore straps. A stress relief hole can be situated at an inner end of theedge.

In accordance with an example embodiment of the present invention, animplantable prosthesis deployment device can include a flexible supportstructure for removable insertion at least partially within an enclosureof an implantable prosthesis. The flexible support structure can occupya total circumferential area and can have an elasticity sufficient togenerate a force sufficient to cause the prosthesis to assume a deployedconfiguration when placed in the prosthesis and after being flexed to anon-deployed configuration. A tab can be adjoined with the flexiblesupport structure and can have a length sufficient to extend external tothe enclosure when the flexible support structure is in a deployedconfiguration in the prosthesis. The flexible support structure can beconfigured in such a way that pulling the tab directionally away fromthe prosthesis when the flexible support structure is inserted in theprosthesis causes a reconfiguration of the flexible support structuresufficient to enable the flexible support structure to pass through anopening in the prosthesis having a total circumferential area that isless than the total circumferential area occupied by the flexiblesupport structure when the prosthesis is in the deployed configuration,thereby enabling removal of the flexible support structure from theenclosure.

In accordance with aspects of the present invention, the flexiblesupport structure can include at least one flexible sheet member. Theflexible sheet member can include two or more portions that do or do notoverlap in a deployed state, depending on the embodiment. The flexiblesupport structure can include a flexible sheet member having one or moreslits or openings disposed therethrough. The one or more slits oropenings can enable the flexible support structure to reconfigure duringremoval of the flexible support structure into a different shape havinga peripheral edge that delineates a reduced effective diameter. Thereconfiguration of the flexible support structure during removal of theflexible support structure can result in a reduced cross-sectionallength of the flexible support structure, a reduced cross-sectionalwidth of the flexible support structure, or both. The flexible supportstructure comprises a flexible framework. The flexible support structurecan be configured to apply a generally radially outward force on aradially outermost surface of the enclosure.

In accordance with aspects of the present invention, the tab can extendthrough the opening in the prosthesis, and the opening can be disposedin and through a layer or surface of the prosthesis, in such a way thatthe central opening provides access to the enclosure. The opening caninclude an outer opening disposed in and completely through the outersurface of the enclosure. The tab can extend through the outer openingin the outer surface of the enclosure. The tab can include one or moreelongate straps.

In accordance with aspects of the present invention, the flexiblesupport structure further can include a separation line extending in agenerally serpentine shape from a central portion of the flexiblesupport structure to a perimeter of the flexible support structure. Theserpentine separation line can follow along a continuous strip ofmaterial. The serpentine separation line can include a plurality ofthrough-holes. The flexible support structure further comprises a stressrelief hole situated at an inner end of the separation line. The tab caninclude one or more straps, and the flexible support structure furthercan include two or more slots for receiving the one or more straps.

In accordance with aspects of the present invention, an edge can extendin a generally serpentine shape from a central portion of the flexiblesupport structure to a perimeter of the flexible support structure. Aremovable connector piece can couple portions of the flexible supportstructure along the edge to each other. The removable connector piececomprises a central portion and one or more elongate portions coupled tothe central portion, and wherein the flexible support structure furthercomprises a plurality of slits for receiving the one or more elongateportions. The tab can include one or more straps, and the flexiblesupport structure further can include two or more slots for receivingthe one or more straps. A stress relief hole can be situated at an innerend of the edge.

In accordance with an example embodiment of the present invention, a kitcan include a prosthesis that is diagrammatically parsable into first,second, third, and fourth quadrants having substantially equal areas.The prosthesis can include an enclosure extending substantially to aperimeter of the prosthesis at least once in at least two of the first,second, third, and fourth quadrants. The kit can include a flexiblesupport structure for removable insertion at least partially within theenclosure. The flexibly support structure can occupy a totalcircumferential area when in a deployed configuration, and theflexibility support structure can have a stiffness sufficient to causethe prosthesis to assume a deployed configuration when placed in theprosthesis. A tab can be adjoined with the flexible support structureand can have a length sufficient to extend external to the enclosurewhen the flexible support structure is in a deployed configuration inthe prosthesis. The flexible support structure can be configured in sucha way that pulling the tab directionally away from the prosthesis whenthe flexible support structure is inserted in the prosthesis causes areconfiguration of the flexible support structure sufficient to enablethe flexible support structure to pass through an opening in theprosthesis having a total circumferential area that is less than thetotal circumferential area occupied by the flexible support structurewhen the prosthesis is in the deployed configuration, thereby enablingremoval of the flexible support structure from the enclosure.

In accordance with an example embodiment of the present invention, asystem can include a deployment device and a prosthesis. The prosthesiscan include a first layer and a second layer forming an enclosure. Thedeployment device can include a flexible support structure configured asa sheet and removably situated at least partially within the enclosure.The flexible support structure can occupy a total circumferential areaand can have an elasticity sufficient to cause the prosthesis toindependently assume a deployed configuration. An edge or a tear linecan extend in a generally serpentine shape from a central portion of theflexible support structure to a perimeter of the flexible supportstructure. A strap can extend from the flexible support structure andexternal to the enclosure. Portions of the flexible support structurealong the edge or tear line can be coupled together prior to removal andcan be configured to separate for removal of the deployment device fromthe prosthesis.

In accordance with aspects of the present invention, the flexiblesupport structure can be configured to be removed through an opening inthe prosthesis having a total circumferential area that is less than thetotal circumferential area occupied by the flexible support structurewhen the prosthesis is in the deployed configuration. The deploymentdevice can include the edge, and the deployment device further caninclude a removable connector piece coupling the portions of theflexible support structure along the edge. An additional strap can becoupled to the removable connector piece for removing the removableconnector piece. The deployment device can include the tear line, andthe tear line can include a plurality of through-holes or a continuousstrip of material. A stress relief hole or opening can be situated inand through the flexible support structure proximate to an inner end ofthe edge or tear line. The edge or a tear line can include one or morebranches connected to one another and each terminating at least oneposition on the flexible support structure.

In accordance with aspects of the present invention, the deploymentdevice can include the separation line in the flexible supportstructure. The separation line can include an inner portion having afirst thickness and an outer portion having a second thickness, and thefirst thickness can be greater than the second thickness. A serpentinethrough-cut can be situated in the flexible support structure and canextend from an inner portion of the flexible support structure to aninner edge of the separation line. The strap can include two strapappendages adapted to assume a locked configuration forming apositioning tool and an unlocked configuration forming a deploymentdevice removal tool.

In accordance an embodiment of the present invention, a method ofremoving a deployment device from a prosthesis includes grasping aflexible support structure forming the deployment device that isremovably disposed at least partially within an enclosure of aprosthesis and occupying a total circumferential area, the flexiblesupport structure having an elasticity that generates a force sufficientto cause the prosthesis to assume a deployed configuration from anon-deployed configuration. The user then pulls the tab of the flexiblesupport structure directionally away from the prosthesis, therebyreconfiguring the flexible support structure to enable the flexiblesupport structure to pass through an opening in the prosthesis having atotal circumferential area that is less than the total circumferentialarea occupied by the flexible support structure when the prosthesis isin the deployed configuration. With continued pulling, the tab of theflexible support structure is removed from the enclosure through theopening.

BRIEF DESCRIPTION OF THE FIGURES

These and other characteristics of the present invention will be morefully understood by reference to the following detailed description inconjunction with the attached drawings, in which:

FIG. 1A depicts a perspective view of an example deployment device,according to aspects of the present invention;

FIG. 1B depicts a top view of the example deployment device of FIG. 1A,according to aspects of the present invention;

FIG. 1C depicts a side view of the example deployment device of FIG. 1A,according to aspects of the present invention;

FIG. 2A depicts an exploded perspective view of an example prosthesis,according to aspects of the present invention;

FIG. 2B depicts a perspective view of the example prosthesis of FIG. 2A,according to aspects of the present invention;

FIG. 2C depicts a side view of the example prosthesis of FIG. 2A,according to aspects of the present invention;

FIG. 3A depicts a perspective view of an example system including theexample deployment device of FIG. 1A positioned in a deployed (e.g.,generally planar) configuration within the example prosthesis of FIG.2A, according to aspects of the present invention;

FIG. 3B depicts a top view of the example system of FIG. 3A when in thedeployed (e.g., generally planar) configuration, according to aspects ofthe present invention;

FIG. 3C depicts a perspective view of the system of FIG. 3A duringremoval of the example deployment device from the example prosthesis,according to aspects of the present invention;

FIG. 3D depicts a side view of the system of FIG. 3A when in thedeployed (e.g., generally planar) configuration, according to aspects ofthe present invention;

FIG. 4A depicts a top view of an example prosthesis and a circledelineating a total circumferential area of the example prosthesis,according to aspects of the present invention;

FIG. 4B depicts a top view of the example prosthesis of FIG. 1A and acircle delineating a total circumferential area of the exampleprosthesis, according to aspects of the present invention;

FIG. 5A depicts a perspective view of another example deployment devicehaving slits or openings, according to aspects of the present invention.

FIG. 5B depicts a perspective view of another example system includingthe example deployment device of FIG. 5A positioned in a deployed (e.g.,generally planar) configuration in the example prosthesis of FIG. 2A,according to aspects of the present invention;

FIG. 5C depicts a perspective view of the example system of FIG. 5Bduring removal of the example deployment device from the exampleprosthesis, according to aspects of the present invention;

FIG. 6A depicts a perspective view of another example deployment deviceincluding one or more overlapping portions, according to aspects of thepresent invention;

FIG. 6B depicts an exploded view of the example deployment device ofFIG. 6A, illustrating the overlapping portions, according to aspects ofthe present invention;

FIG. 6C depicts a perspective view of the example deployment device ofFIG. 6A positioned in a deployed (e.g., generally planar) configurationin the example prosthesis of FIG. 2A, according to aspects of thepresent invention;

FIGS. 7A through 7C depict top views of example deployment deviceshaving overlapping portions, according to aspects of the presentinvention;

FIGS. 7D through 7F depicts top views of example deployment devicesforming frameworks, according to aspects of the present invention;

FIG. 8 depicts a side view of another example deployment deviceincluding two portions that are operationally connected by a tabincluding an elongate strap, according to aspects of the presentinvention;

FIG. 9 depicts a perspective view of another example prosthesis,according to aspects of the present invention;

FIG. 10A depicts a perspective view of another example embodiment of adeployment device forming a framework and adapted for the exampleprosthesis of FIG. 9, according to aspects of the present invention;

FIG. 10B depicts a perspective view of an example system including theexample deployment device of FIG. 10A positioned in a deployed (e.g.,generally planar) configuration in the example prosthesis of FIG. 9,according to aspects of the present invention;

FIG. 11A depicts a perspective view of another example deployment deviceforming a framework and having two tabs each forming a protrudingsegment, according to aspects of the present invention;

FIG. 11B depicts a perspective view of an example system including theexample deployment device of FIG. 11A positioned in a deployed (e.g.,generally planar) configuration in the example prosthesis of FIG. 9,according to aspects of the present invention;

FIG. 11C depicts a side view of the example system of FIG. 11B when inthe deployed (e.g., generally planar) configuration, according toaspects of the present invention;

FIG. 110 depicts a perspective view of the example system of FIG. 11Bduring removal of the example deployment device from the exampleprosthesis, according to aspects of the present invention;

FIG. 12A depicts a top view of another example deployment device forminga framework and including an insertion device, according to aspects ofthe present invention;

FIG. 12B depicts a perspective view of an example system including theexample deployment device of FIG. 12A inserted in a non-deployed (e.g.,rolled up or non-planar) configuration in the example prosthesis of FIG.9, according to aspects of the present invention;

FIG. 12C depicts a perspective view of the example system of FIG. 12B ina deployed (e.g., generally planar) configuration, according to aspectsof the present invention;

FIG. 13 depicts a kit according to embodiments of the present invention;

FIG. 14 depicts a top view of a flexible support structure having aserpentine separation line extending from an inner portion thereof to aperimeter thereof, according to embodiments of the present invention;

FIG. 15 depicts a removable connector piece for operationally adjoiningportions of the flexible support structure of FIG. 14 along theserpentine separation line, according to aspects of the presentinvention;

FIG. 16A depicts a top view of the flexible support structure of FIG. 14with the removable connector piece of FIG. 15 situated therein,according to embodiments of the present invention;

FIG. 16B depicts a bottom view of the flexible support structure of FIG.14 with the removable connector piece of FIG. 15 situated therein,according to embodiments of the present invention;

FIG. 17 depicts a perspective view of a strap for use in removing theflexible support structure FIGS. 16A and 16B, according to aspects ofthe present invention;

FIG. 18 depicts the removable connector piece of FIG. 15 with anadditional strap for use in removal of the removable connector piecefrom the flexible support structure of FIG. 15, according to aspects ofthe present invention;

FIG. 19A depicts a top perspective view of a deployment deviceincorporating the components of FIGS. 14 through 18, according toaspects of the present invention;

FIG. 19B depicts a bottom perspective view of the deployment device ofFIG. 19A, according to embodiments of the present invention;

FIG. 20 depicts a perspective view of the deployment device of FIGS. 19Aand 19B positioned within the prosthesis of FIGS. 2A through 2C;

FIG. 21A depicts a perspective view of a deployment device having aserpentine separation line that includes a plurality of perforations,according to embodiments of the present invention;

FIG. 21B depicts a perspective view of a deployment device having aserpentine separation line that has been separated to form a serpentineedge;

FIG. 22 depicts a close-up view of a central portion of the deploymentdevice of FIG. 21, according to aspects of the present invention;

FIG. 23 depicts the deployment device of FIG. 21, further including astress relief hole at an inner end of the serpentine separation line,according to embodiments of the present invention;

FIG. 24 depicts a perspective view of a deployment device having aserpentine separation line that includes a continuous strip of material,according to embodiments of the present invention;

FIG. 25A depicts a perspective view of the deployment device of FIG. 24situated within the prosthesis of FIGS. 2A through 2C;

FIG. 25B depicts a perspective view of the deployment device of FIG. 25Aassuming a helix (e.g., a conventional serpentine staircase)configuration during removal from a defect or opening in an artificialmuscle wall, according to aspects of the present invention;

FIGS. 26A, 26B, and 26C depict a perspective view, a side view, and aclose up view, respectively, of a cross section of reinforcing lipsabutting the serpentine separation line, according to aspects of thepresent invention;

FIGS. 27A and 27B depict a perspective view and a bottom view,respectively, of the flexible support structure of FIGS. 26A through26C, according to embodiments of the present invention;

FIG. 28 depicts a perspective view of a deployment device having aserpentine separation line that includes two contiguous portions ofunequal thicknesses, according to embodiments of the present invention;

FIG. 29A depicts a top view of a flexible support structure having analternative serpentine separation line with a plurality of branches,according to embodiments of the present invention;

FIG. 29B depicts a top view of a flexible support structure having yetanother alternative serpentine separation line with a plurality ofbranches, according to embodiments of the present invention;

FIG. 30 depicts a strap in an unassembled (e.g., substantially flat)configuration that is adapted to serve as both a positioning device anddeployment device removal tool, according to an example embodiment ofthe present invention;

FIG. 31A depicts the strap of FIG. 30 in a deployment device situated ina prosthesis, and in a locked position forming a positioning tool,according to aspects of the present invention; and

FIG. 31B depicts the strap of FIG. 31A in an unlocked position forming adeployment device removal tool, according to aspects of the presentinvention.

DETAILED DESCRIPTION

An illustrative embodiment of the present invention relates to adeployment device capable of deploying a prosthesis, such as a herniapatch, with a more elegant and efficient design than other conventionaldeployment devices. The deployment device includes a flexible supportstructure that fits at least partially within an enclosure of theprosthesis, such as one or more pockets in the prosthesis formed by twostacked layers adjoined at a peripheral edge thereof. The flexiblesupport structure has an elasticity that is sufficient to cause theprosthesis to deploy after implantation (e.g., by causing the prosthesisto independently assume a deployed, e.g., generally planar, shape afterbeing implanted in a rolled or otherwise deformed configuration) and aflexibility sufficient to enable bending, folding, or otherwise assuminga collapsed or distorted configuration for removal from the prosthesis.In particular, the flexible support structure can have a flexibilitysufficient to enable the flexible support structure to pass through anopening in the prosthesis that has a total circumferential area that issmaller than a total circumferential area of the deployment device. Thedeployment device additionally can include a tab that extends externalto the enclosure and that, when pulled in a direction away from theprosthesis, causes the flexible support structure to reconfigure in amanner sufficient for removal of the flexible support structure.

Accordingly, the deployment device according to the illustrativeembodiment of the present invention can have an elasticity that issufficient for causing the prosthesis to assume a deployed (e.g.,generally planar and non-collapsed) configuration at a target site evenafter being collapsed, compressed, or distorted in some manner (e.g.,for implantation), and a flexibility sufficient for being removed fromthe prosthesis.

As utilized herein, the term “flexibility” adopts its conventionalmeaning in the art of the pliability of an object or extent to which anobject permits bending. Flexibility thus includes bending due todifferent types of deformation, e.g., elastic deformation, plasticdeformation, etc.

The term “elasticity” generally refers to the ability of an object toreversibly deform under stress, as is well known in the art. Elasticitythus endows an object with the ability to return to its original shapeafter the removal of stress (e.g., one or more external forces) thatproduced deformation of the object. Elasticity encompasses the abilityof an object to return to a shape subsequent to deformation produced byexpansion (e.g., elongation) and deformation produced by compression(e.g., as caused by folds, bends, etc. in an object).

FIGS. 1 through 31B, wherein like parts are designated by like referencenumerals throughout, illustrate example embodiments of a deploymentdevice according to the present invention. Although the presentinvention will be described with reference to the example embodimentsillustrated in the figures, it should be understood that manyalternative forms can embody the present invention. One of skill in theart will appreciate many different ways to alter the parameters of theembodiments disclosed, such as the size, shape, or type of elements ormaterials, in a manner still in keeping with the spirit and scope of thepresent invention.

FIG. 1A depicts a perspective view of an example embodiment of adeployment device 100 according to the present invention. FIG. 18further depicts the example deployment device 100 from a top view, andFIG. 1C further depicts a side view thereof. The deployment device 100includes a flexible support structure 102 and one or more labs 104. Theflexible support structure 102 can include any of a wide variety ofdifferent shapes, forms, portions, and members. In the exampleembodiment of FIG. 1A, the flexible support structure 102 is generallycircular in shape and forms a substantially flat sheet member having twoportions 106. The two portions 106 each include a radially distal end108 and a radially proximal end 110. The two portions 106 are adjoinedat the radially proximal end 110. Alternatively, the two (or more)portions 106 can be adjoined at other positions or ends thereof. Boththe flexible support structure 102 and the one or more tabs 104 canpossess a substantially uniform thickness, or can have a thickness thatvaries across different positions thereon.

The one or more tabs 104 can be any protruding portion or member. Asillustrative, non-limiting examples, the one or more tabs 104 caninclude elongate straps, flaps, strips of material, appendages,protuberances, any other protruding portion or member, portions thereof,or combinations thereof. As depicted in FIG. 1A, the tabs 104 of thefirst example embodiment include two elongate straps adjoined with theflexible support structure 102 at or near the proximal end 110. Theflexible support structure 102 and the tabs 104 can be constructed ofextruded polypropylene, low density polyethylene (LDPE), other plasticmaterial, monofilament material, sheet material, or any other suitablebiodegradable or non-biodegradable material, as would be appreciated byone of skill in the art upon reading the present specification.

FIG. 2A depicts an exploded view of an example prosthesis 112. Theexample prosthesis 112 is further illustrated in FIG. 2B from aperspective view and in FIG. 2C from a cross-sectional side view. Theexample prosthesis 112 can be formed of two or more stacked layers. Thetwo or more stacked layers can include a first (e.g., top) layer 114 anda second (e.g., bottom) layer 116. The first layer 114 and the secondlayer 116 each can be a flexible sheet mesh. As non-limiting examples,the mesh can be constructed from polytetrafluoroethylene (PTFE), othersuitable fluoropolymer materials, or any other suitable material. Thefirst layer 114 and the second layer 116 can be adjoined (e.g., affixed,coupled, adhered, fastened, sewn, stitched, or otherwise joinedtogether) at a seam (e.g., the outer perimeter 118 of the first layer114). In illustrative embodiments depicted herein, the first layer 114and the second layer 116 can be adjoined at or near the outer perimeter118 of the first layer 114, so as allow for the formation of anenclosure 124 that extends substantially to the outer perimeter 118 ofthe first layer 114, substantially to the outer perimeter 120 of thesecond layer 116, or both (as depicted in the example embodiment of FIG.2A through 2C).

The prosthesis 112 can include a portion 126 between the outer perimeterof the first layer 114 and the outer perimeter of the second layer 116for serving as a flap for suturing the prosthesis 112 during fixation,e.g., in laparoscopic repairs. Alternatively, fixation can be performedby affixing (tacking, suturing, etc.) the first layer 114, e.g., duringopen hernia repairs. In general, the present invention is not limited toany particular fixation procedure. Rather, one of skill in the art willappreciate a wide variety of ways to affix the prosthesis 112, dependingon the particular type of surgical procedure.

Furthermore, it should be appreciated that the example prosthesis 112 ofFIGS. 2A through 2C is not intended to limit embodiments of the presentinvention. Thus, although the example embodiments described herein makerepeated reference to the exemplary prostheses of the figures (e.g.,hernia patches), embodiments of the present invention can be adapted forand utilized in any conventional, known, or otherwise suitableprosthesis, as would be appreciated by one of skill in the art uponreading the present specification.

The first layer 114 can include an aperture or opening 122 disposedtherein and therethrough, e.g., for enabling access to the enclosure124. The opening 122 can form an inner perimeter 134 on the prosthesis112. As illustrated in FIGS. 2A through 2C, the opening 122 can consistof an inner opening in the first layer 114, i.e., contained entirelywithin the outer perimeter 118 of the first layer 114. Furthermore, theopening 122 can be a central opening, i.e., substantially centered inthe first layer 114. Alternatively, the opening 122 can be situatedelsewhere on the first layer 114 or on the second layer 116, and/or canextend to an edge thereof. While the opening 122 is depicted asgenerally circular in shape, the opening 122 can have any desired shape,including (as non-limiting examples) a general shape of an oblong, apolygon, an oval, a star, a triangle, a rectangle, a pentagon, ahexagon, etc. Furthermore, the opening 122 can be shaped to mimic theshape of the flexible support structure 102, or to mimic one or moreportions of the flexible support structure 102. Alternatively, theopening 122 may be tailored and/or trimmed (e.g., to mimic the shape ofthe flexible support structure 102) by a surgeon immediately prior toplacement of the prosthesis 112, as would be appreciated by one of skillin the art upon reading the present specification.

FIG. 3A depicts an example system that includes the prosthesis 112 ofFIGS. 2A through 2C and the deployment device 100 of FIGS. 1A through 1Cinserted into the prosthesis 112. The tabs 104 extend external to theenclosure 124, e.g., protrude beyond an outer edge of the enclosure 124.The flexible support structure 102 extends substantially to an outerperimeter of the prosthesis 112 (in this case, extends substantially toboth the outer perimeter 118 of the first layer 114 and the outerperimeter 120 of the second layer 116). In some embodiments, theflexible support structure 102 extends to and is in contact with aradially outermost surface 125 of the enclosure 124 when the flexiblesupport structure 102 is in a deployed (e.g., generally planar)configuration. Accordingly, the flexible support structure 102 can beconfigured to apply a generally radially outward force on the radiallyoutermost surface 125 of the enclosure 124 when in the deployed (e.g.,generally planar) configuration.

As depicted in FIG. 3A, the deployment device 100 can assume a deployed(e.g., generally planar) configuration within the prosthesis 112. Morespecifically, in the example embodiment of FIG. 3A, the deployed (e.g.,generally planar) configuration of the deployment device 100 ischaracterized by an absence of folds, creases, bends, buckling, and thelike in the flexible support structure 102. The deployed (e.g.,generally planar) configuration can cause the prosthesis 112 tosimilarly assume a deployed (e.g., generally planar) configuration. Forexample, the size and/or shape of the flexible support structure 102 canbe sufficient to cause the prosthesis 112 to deploy when the flexiblesupport structure 102 is in a deployed (e.g., generally planar)configuration.

FIG. 3B further depicts a top view of the system of FIG. 3A of thedeployment device 100 and the prosthesis 112. For clarity, the tabs 104are not shown. FIG. 3B illustrates that the prosthesis 112 can bediagrammatically parsed into four quadrants of substantially equalareas, quadrant I, quadrant II, quadrant III, and quadrant IV. The fourquadrants I, II, III, and IV are divided by a horizontal axis 130 and avertical axis 128 that pass through a center point 132 of the prosthesis112. In illustrative embodiments, the enclosure 124 (not visible in thetop view of FIG. 3B) can be formed in such a way as to extendsubstantially to a perimeter of the prosthesis 112 (e.g., outerperimeter 118 of the first layer 114 or outer perimeter 120 of thesecond layer 116) at least once in at least two of the four quadrants I,II, III, and IV. Furthermore, the enclosure 124 can extend to aperimeter of the prosthesis 112 at least once in at least one, in atleast three, or in all four of the quadrants I, II, III, and IV. Theenclosure 124 can form a closed loop around the center point 132, e.g.,can extend around the inner perimeter 134 formed by the opening 122, asdepicted in the example embodiment of FIGS. 3A through 3C.

Additionally, the flexible support structure 102 can extend into theenclosure 124 in at least one, in at least two, in at least three, or inall four of the quadrants I, II, III, and IV. In illustrativeembodiments, and as depicted in FIG. 3B, the flexible support structure102 extends substantially to an outer perimeter of the prosthesis 112(e.g., the outer perimeter 118 and/or the outer perimeter 120) at leastonce in at least two of the four quadrants I, II, III, and IV. Infurther illustrative embodiments, the flexible support structure 102extends substantially to an outer perimeter of the prosthesis 112 (e.g.,the outer perimeter 118 and/or the outer perimeter 120) at least once inat least three of the four quadrants I, II, III, and IV. In yet furtherillustrative embodiments, the flexible support structure 102 extendssubstantially to an outer perimeter of the prosthesis 112 (e.g., theouter perimeter 118 and/or the outer perimeter 120) at least once in allfour of the four quadrants I, II, III, and IV.

Continuing with FIG. 3A, the tabs 104 can extend external to theenclosure 124. For example, as illustrated, both of the tabs 104 extendout of the opening 122 when the deployment device 100 is situated in theprosthesis 112. (Alternatively, the tabs 104 can be configured to extendbelow the opening, as described in a later embodiment depicted withreference to FIG. 10B.) In such embodiments where the tabs 104 extendout of the opening 122, the tabs 104 can assume a non-flatconfiguration, e.g., as depicted in FIG. 3A. However, the tabs 104further can be configured to assume a flat configuration, as depicted inthe example embodiment of FIG. 3D. For instance, the tabs 104 can becoupled to the flexible support structure 102 by a hinge or canotherwise be enabled to hinge or pivot relative to the flexible supportstructure 102. This can enable the deployment device 100 to assume asubstantially flat configuration that may be useful in reducing the sizeof packaging required to sell the deployment device 100. Accordingly, insuch embodiments where the tabs 104 are packaged in a flatconfiguration, the tabs 104 subsequently can be moved into a more usablenon-flat configuration (e.g., as depicted in FIG. 3A) after removal fromthe packaging.

The tabs 104 can be constructed of a material that is rigid (e.g., thatis stiffer than the flexible support structure 102), to facilitateintraoperative maneuvering by a surgeon of the prosthesis 112 when thedeployment device 100 is positioned in the prosthesis 112.Alternatively, the tabs 104 can be constructed of material that is moreflexible than the flexible support structure 102. In general, one ofskill in the art will appreciate a wide variety of suitable materialsthat can be utilized in making the tabs 104.

The flexible support structure 102 can be formed of a material having anelasticity that is sufficient to cause the flexible support structure102 to independently assume a deployed (e.g., generally planar)configuration, e.g., in the absence of an external collapsing forceapplied by a surgeon or other operator handling the deployment device100. For example, the elasticity of the material of the flexible supportstructure 102 can be sufficient to cause the flexible support structure102 to independently return to a deployed (e.g., generally planar)configuration after being rolled, etc. for insertion into a patient.Accordingly, after inserting the flexible support structure 102 into theprosthesis 112 and implanting the prosthesis 112 (e.g., in a rolled orfolded configuration), the elasticity of the flexible support structure102 causes the flexible support structure 102 and the prosthesis 112 to“spring” back into (or otherwise assume) the deployed (e.g., generallyplanar) configuration.

The flexible support structure 102 can be provided with a particularthickness and material type that results in the desired values offlexibility and elasticity. For example, in some embodiments of thepresent invention implemented for open hernia repairs, the flexiblesupport structure 102 is constructed of extruded polyester orpolypropylene having a substantially uniform thickness of about 0.0075inches to about 0.010 inches. One of skill in the art will appreciatethat this thickness value represents a device that is substantiallythinner than existing prior art deployment devices utilizing permanentrings or frame members.

Furthermore, the flexibility of the flexible support structure 102 canbe sufficiently high to enable the flexible support structure 102 toassume a collapsed configuration (e.g., folded, bent, etc.) duringremoval of the deployment device 100 from the prosthesis 112, e.g.,while the prosthesis 112 is being held in place. For example, an upwardtensile force exerted by a surgeon on the flexible support structure 102by pulling the tabs 104 in a direction away from the affixed prosthesis112 can initiate the bending, folding, collapsing, or otherreconfiguration in shape of the flexible support structure 102 necessaryto liberate the flexible support structure 102 from the enclosure 124 ofthe prosthesis 112. This is depicted in FIG. 3C, which illustrates thedeployment device 100 of FIG. 3A during removal from the prosthesis 112.

As one example, the deployment device 100 can be removed by holding theprosthesis 112 in a fixed position (e.g., using sutures or tacks tosecure the prosthesis in place against tissue, muscle wall, etc.) andsimultaneously pulling the tabs 104 in a direction away from theprosthesis 112, such as an upward direction 140 (see FIG. 3C). Duringsuch a process, the flexible support structure 102 experiences an upwardforce at the position where the tabs 104 are joined with the flexiblesupport structure 102. The upward force causes the flexible supportstructure 102 to lift up off the second layer 116 and encounter thefirst layer 114. The lifting motion can cause the enclosure 124 toexpand in height, as the first layer 114 similarly lifts in response tocontact with the flexible support structure 102. As the upward pullcontinues, portions of the flexible support structure 102 contacting thefirst layer 114 experience a downward force resisting the upward motion,while other portions not covered by the first layer 114 (e.g.,positioned directly beneath the opening 122) do not experience suchresistance. The difference in applied forces causes the flexible supportstructure 102 to undergo a reconfiguration (e.g., a deformation inshape, orientation, or both) sufficient to enable the flexible supportstructure 102 to reduce its effective cross-sectional area and passthrough the opening 122 in the prosthesis 112. For example, thereconfiguration of the flexible support structure 102 can include atleast one bend, fold, crease, buckle, or other collapsing action orstate.

The size and/or orientation of the flexible support structure 102 can bedifferent from the shape and/or size of the opening 122. In illustrativeembodiments, the flexible support structure 102 is larger in size (e.g.,in one or more dimensions, in area, in volume occupied, effectivecross-sectional area, or the like) than the opening 112. For instance,in embodiments where the flexible support structure 102 has a generallycircular top profile shape, the flexible support structure 102 can havean effective diameter that is greater than a diameter of the opening122. In embodiments where the flexible support structure 102 has agenerally non-circular top profile shape, the flexible support structure102 can have a length or a width that is greater than a length or widthof the opening 122. Stated differently, the flexible support structure102, when positioned in the prosthesis 112 in a deployed (e.g.,generally planar) configuration, generally can have a top profile shapethat extends beyond a top profile shape of the opening 112.

Additionally, the opening 122 can have a total circumferential area thatis less than a total circumferential area occupied by the flexiblesupport structure 102 when the prosthesis 112 and the flexible supportstructure 102 are in the deployed (e.g., generally planar) configuration(as depicted in FIG. 3A). In further embodiments, the opening 122 canhave a total circumferential area that is substantially less than thetotal circumferential area occupied by the flexible support structure102 when the prosthesis 112 and the flexible support structure 102 arein the deployed (e.g., generally planar) configuration. In yet furtherembodiments, the opening 122 can have a total circumferential area thatis significantly less than the total circumferential area occupied bythe flexible support structure 102 when the prosthesis 112 and theflexible support structure 102 are in the deployed (e.g., generallyplanar) configuration. As some examples, and depending on the particularshape of the prosthesis 112, the flexible support structure 102 (when ina deployed (e.g., generally planar) configuration in the prosthesis 112)can have a total circumferential area that is about 5% more, about 10%more, about 15% more, about 20% more, about 25% more, about 30% more,about 35% more, about 40% more, about 45% more, about 50% more, about55% more, about 60% more, about 65% more, about 70% more, about 75%more, about 80% more, about 85% more, about 90% more, about 95% more,about 100% more, about 105% more, about 110% more, about 115% more,about 120% more, about 125% more, about 130% more, about 135% more,about 140% more, about 145% more, about 150% more, about 155% more,about 160% more, about 165% more, about 170% more, about 175% more,about 180% more, about 185% more, about 190% more, or about 195% more,about 200% more, or greater than about 200% more (or some intermediatevalue lying therebetween) than a total circumferential area occupied bythe opening 122.

The total circumferential area of the flexible support structure 102generally can be defined as the area of the smallest theoretical circlethat can be constructed to fully contain, on or inside its perimeter,the entire profile of the flexible support structure 102 when viewedfrom the directly above (e.g., from the top view of FIG. 3B). Forexample, FIG. 4A depicts another example of a flexible support structure102 having a plurality of adjoined appendages 136, which can havedifferent lengths. Each appendage 136 includes a distal end 108 and aproximal end 110. A theoretical circle 138 is illustrated in bold,dashed lines, which encloses the entire profile of the flexible supportstructure 102 when viewed from above. The theoretical circle 138 is thesmallest possible theoretical circle that can be constructed around theprosthesis 102, since the theoretical circle 138 contains (in or on itsperimeter) the entire profile of the flexible support structure 102 andsince the perimeter of the flexible support structure 102 intersectswith at least three points on theoretical circle 138. Accordingly, FIG.4B depicts the smallest theoretical circle 138 containing (in or on itsperimeter) the entire top view profile of the flexible support structure102 of FIGS. 1A through 1C. Similarly, the total circumferential area ofthe opening 122 also can be determined in this way.

Accordingly, during removal, the flexible support structure 102 canassume a reconfiguration wherein the flexible support structure 102possesses an increased height, e.g., as compared to a height of theflexible support structure 102 in a deployed (e.g., generally planar)configuration. Additionally, during removal, the flexible supportstructure 102 can assume a reconfiguration characterized by a reducedtotal circumferential area. For example, this is illustrated in FIG. 3C,which to shows the flexible support structure 102 during removal havinga three-dimensional shape generally resembling that of a cone possessinga height that is greater than the height of the sheet members formingthe portions 106 of the deployed (e.g., generally planar) flexiblesupport structure 102 depicted in FIG. 3A. For example, in illustrativeembodiments adapted for open hernia repair, the flexible supportstructure 102 can be transformed from a nearly contiguous flat circlehaving a diameter of about 2.6 inches to a configuration suitable forfitting through a circular orifice area having a diameter of about 0.5inches. One of skill in the art will appreciate that these values areillustrative and do not limit the present invention.

In illustrative embodiments, the flexible support structure 102 can bedisposed within the enclosure 124 of the prosthesis 112 and can occupy atotal circumferential area therein in such a way that causes theprosthesis 112 to be in a deployed (e.g., generally planar)configuration, e.g., as depicted in FIG. 3A.

Although FIGS. 1A through 1C depict the example flexible supportstructure 102 as having only two portions 106, the flexible supportstructure 102 can have more or less such portions. For instance, FIG. 5Adepicts another example embodiment of the deployment device 100 thatconsists of four such portions 106. The four portions 106 are dividedinto substantially equal areas and have substantially similar shapes anddimensions. In alternative embodiments, the shapes, areas, anddimensions of the various portions 106 can vary, e.g., based on theshape of the prosthesis 112 into which the flexible support structure102 will fit. Some or all of the portions 106 can be separated from oneanother by thin elongate openings, such as the slits 142. The slits 142can enable the flexible support structure 102 to reconfigure duringremoval from the prosthesis 112 into a different shape having aperipheral edge that delineates a reduced diameter or effectivediameter, i.e., a diameter that is less than the diameter of theperipheral edge of the flexible support structure 102 when in a deployed(e.g., generally planar) configuration in the prosthesis 112. FIG. 5Bdepicts the deployment device 100 positioned in the prosthesis 112 in adeployed (e.g., generally planar) configuration, and FIG. 5C furtherdepicts the deployment device 100 during removal from the prosthesis112.

When in a deployed (e.g., generally planar) configuration, one or moreof the portions 106 can be non-overlapping, e.g., as illustrated inFIGS. 3A and 5B. Alternatively, one or more of the portions 106 can beoverlapping. For example, FIG. 6A illustrates another example embodimentthat includes three portions 106 a, 106 b, and 106 c, each of whichoverlaps with its two adjacent portions. This can be seen in FIG. 6B,which depicts the three portions 106 a, 106 b, and 106 e from anexploded view. The portion 106 b includes a flap 144 b that is coveredby the portion 106 a when in the deployed (e.g., generally planar)configuration. Similarly, the portion 106 c includes a flap 144 c thatis covered by the portion 106 b when in the deployed (e.g., generallyplanar) configuration. Furthermore, the portion 106 a includes a flap144 a that is covered by the portion 106 c when in the deployed (e.g.,generally planar) configuration. FIG. 6C further depicts the deploymentdevice of FIG. 6A positioned within the prosthesis 112.

The portions 106 of the flexible support structure 102 generally cantake on a wide range of other shapes, relative dimensions, and/or sizes.For example, FIGS. 7A through 7F depict additional embodiments offlexible support structure 102. One of skill in the art will appreciatethat these examples are provided for purposes of further illustrationand are not intended as limiting. Rather, a wide variety of differentflexible support structures 102 and openings 122 having still othershapes, sizes, relative dimensions, and/or orientations, andcombinations thereof, are possible and contemplated by the presentinvention.

FIG. 7A depicts a flexible support structure 102 according to oneexample embodiment of the present invention, which includes sixoverlapping portions 106 each generally shaped to resemble a distortedrectangle. FIG. 7B depicts a flexible support structure 102 according toanother example embodiment of the present invention, which includes sixoverlapping portions 106 each generally shaped to resemble a circle.FIG. 7C depicts a flexible support structure 102 according to yetanother example embodiment of the present invention, which includes sixoverlapping portions 106 each generally shaped to resemble a distortedtriangle.

Furthermore, while embodiments provided herein include a flexiblesupport structure 102 generally formed from sheet members, otherembodiments are possible having different shapes and forms. Forinstance, the flexible support structure 102 can take the form of aframework, as depicted in the example embodiments of FIGS. 7D through 7Fdepict. More specifically, FIG. 7D depicts a flexible support structure102 according to another example embodiment of the present invention,which forms a framework having three portions 106 adjoined by a proximalring 146. FIG. 7E depicts a flexible support structure 102 according toanother example embodiment of the present invention, which forms aframework having four appendages 136 adjoined by a central portion 106.FIG. 7F depicts a flexible support structure 102 according to anotherexample embodiment of the present invention, which forms a frameworkhaving two portions 106 each generally shaped as a semicircle, e.g.,which mimics in shape an edge of the enclosure 124 on the prosthesis112. Yet other types and placements of portions connecting one or moreof appendages 136 are possible.

Although the example embodiments of flexible support structures 102depicted herein generally include various portions 106 that areconnected to one another on the flexible support structure 102, otherembodiments of flexible support structure 102 can include two or moreportions 106 that are not connected on the flexible support structure.For instance, FIG. 8 depicts a side view of an alternative embodiment ofa deployment device 100 that includes two portions 106 that areoperationally connected to one another by the tab 104. In particular,the tab 104 forms a U-shaped elongate strap that extends away from theflexible support structure 102 and is folded at its distal end 148. Thetab 104 joins with each of the portions 106, e.g., is formed integraltherewith, is affixed thereto, is sewn thereto, is stitched thereto, iscoupled thereto, is fastened thereto, is adhered thereto, or isotherwise joined therewith.

The example embodiments of FIGS. 1A through 8 are adapted for agenerally circularly shaped prosthesis 112. However, embodiments of thepresent invention alternatively can be implemented for prostheses 112having other (e.g., non-circular) shapes. In such alternativeembodiments, the deployment device 100 can include the flexible supportstructure 102 of any of FIGS. 1A through 8, e.g., adjusted such that ithas an outer perimeter that mimics the shape of the outer perimeter 118of the first layer 114, the outer perimeter 120 of the second layer 116,or both.

For example, FIG. 9 depicts an additional example embodiment of theprosthesis 112, wherein the first layer 114 and the second layer 116 areboth generally shaped as a rectangle (more specifically, a rectanglehaving rounded corners). The first layer 114 and the second layer 116are adjoined and enable formation of an enclosure 124 therebetween, aswith the example prosthesis 112 of FIGS. 2A through 2C. FIG. 10A depictsan illustrative embodiment of the deployment device 100 adapted for theprosthesis 112 of FIG. 10A. As illustrated, the deployment device 102includes a framework having a generally rectangular shape (e.g.,generally bulged rectangular shape or generally rectangular shape withrounded edges). The tab 104 is a protruding flap that extends from oneside of the flexible support structure 102 toward another (e.g.,opposite) side of the flexible support structure 102. The tab 102 canhave a length sufficient to enable the tab 102 to be grasped and pulledfor removal.

FIG. 10B depicts the deployment device 100 of FIG. 10A placed in theprosthesis 112 of FIG. 9. As with the example embodiments of FIGS. 1Athrough 8, the one or more tabs 104 can extend external to the enclosure124 (e.g., can protrude beyond an outer edge of the enclosure 124).Furthermore, the flexible support structure 102 extends into theenclosure 124 in at least one, in at least two, in at least three, or inall four of the substantially equal-area quadrants I, II, III, and IVinto which the prosthesis 112 can be diagrammatically parsed.Furthermore, in illustrative embodiments, and as depicted in FIG. 10B,the flexible support structure 102 extends substantially to an outerperimeter of the prosthesis 112 (e.g., the outer perimeter 118 and/orthe outer perimeter 120) at least once in at least two of the fourquadrants I, II, III, and IV. In further illustrative embodiments, theflexible support structure 102 extends substantially to an outerperimeter of the prosthesis 112 (e.g., the outer perimeter 118 and/orthe outer perimeter 120) at least once in at least three of the fourquadrants I, II, III, and IV. In yet further illustrative embodiments,the flexible support structure 102 extends substantially to an outerperimeter of the prosthesis 112 (e.g., the outer perimeter 118 and/orthe outer perimeter 120) at least once in all four of the four quadrantsI, II, III, and IV.

The tab 104 can be located at a position on the flexible supportstructure 102 that divides a length 152 of the flexible supportstructure 102 in two equal halves, as depicted in FIG. 10B.Alternatively, the tab 104 can be located elsewhere on the flexiblesupport structure 102. The tab 104 can extend across some percentage ofa length 150 of the opening 122. As illustrative examples, the tab 104can extend across about 5%, about 10%, about 15%, about 20%, about 25%,about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, about60%, about 65%, about 70%, about 75%, about 80%, about 85%, about 90%,about 95%, or about 100% of the length 150 of the opening 122, or atanother amount, e.g., which is sufficient to enable the tab 104 to begripped for removal of the deployment device 100 from the prosthesis112.

Furthermore, although certain embodiments described and depicted hereinprovide that the one or more tabs 104 protrude through or beneath theopening 112, the tabs 104 alternatively or additionally can beconfigured to protrude through different openings disposed in andthrough other portions of the prosthesis 112. For example, FIG. 11Adepicts an alternative embodiment of the deployment device 100, whichincludes two tabs 104 that are adjoined with the flexible supportstructure 102 and which extend from one or more connection points in anoutward direction away from a center point of the flexible supportstructure 102, e.g., which extend beyond an outer edge of the flexiblesupport structure 102. Each of the two tabs 104 in the exampleembodiment of FIG. 11A include a protruding segment that deviates fromextends beyond the generally rectangular shape (as non-limitingexamples, generally bulged rectangular shape, or generally rectangularshape with rounded edges) of the flexible support structure 102. FIG.11B depicts the deployment device 100 disposed within the prosthesis112. As can be seen from FIG. 11B, the tabs 104 extend transversallybeyond an outer edge of the prosthesis 112.

Accordingly, the tabs 104 can extend through an opening 154 disposed inand through a side of the prosthesis 112. Although the opening 154 isnot visible from the perspective view of FIG. 11B, the position of theopening 154 is referenced, for clarity. As just one non-limitingexample, the opening 154 in the prosthesis 112 can be formed institching that connects the first layer 114 and the second layer 116.The tabs 104 can extend over the second layer 116, through the opening154, and beyond the outer perimeter 120 of the second layer 116 (e.g.,beyond the perimeter of the prosthesis 112), as illustrated in FIG. 11B.The opening 154 is further depicted from a side view in FIG. 11C.

As described previously with regard to the example embodiments of FIGS.1A through 8, the size and/or orientation of the flexible supportstructure 102 can be different from the shape and/or size of the opening154 through which the one or more tabs 104 extend. In illustrativeembodiments, the flexible support structure 102 is larger in size (e.g.,in one or more dimensions, in area, in volume occupied, or the like)than the opening 154. For instance, in some embodiments, the flexiblesupport structure 102 has a length 152 that is greater than a length 158of the opening 154. As another example, the flexible support structure102, when positioned in the prosthesis 112 and when in a deployed (e.g.,generally planar) configuration therein, can have a profile (as viewedfrom above, e.g., the top view of FIG. 3B) that includes at least oneportion that is non-overlapping with a corresponding profile (as viewedfrom above) of the opening 112.

Furthermore, the opening 112 can have a total circumferential area thatis less than a total circumferential area occupied by the flexiblesupport structure 102 when the prosthesis 112 and the flexible supportstructure 102 are in the deployed (e.g., generally planar) configuration(as depicted in FIG. 3A). In further embodiments, the opening 154 canhave a total circumferential area that is substantially less than thetotal circumferential area occupied by the flexible support structure102 when the prosthesis 112 and the flexible support structure 102 arein the deployed (e.g., generally planar) configuration. In yet furtherembodiments, the opening 154 can have a total circumferential area thatis significantly less than the total circumferential area occupied bythe flexible support structure 102 when the prosthesis 112 and theflexible support structure 102 are in the deployed (e.g., generallyplanar) configuration. As some examples, and depending on the particularshape of the prosthesis 112, the flexible support structure 102 (when ina deployed, e.g., generally planar, configuration in the prosthesis 112)can have a total circumferential area that is about 5% more, about 10%more, about 15% more, about 20% more, about 25% more, about 30% more,about 35% more, about 40% more, about 45% more, about 50% more, about55% more, about 60% more, about 65% more, about 70% more, about 75%more, about 80% more, about 85% more, about 90% more, about 95% more,about 100% more, about 105% more, about 110% more, about 115% more,about 120% more, about 125% more, about 130% more, about 135% more,about 140% more, about 145% more, about 150% more, about 155% more,about 160% more, about 165% more, about 170% more, about 175% more,about 180% more, about 185% more, about 190% more, or about 195% more,about 200% more, or greater than about 200% more (or some intermediatevalue lying therebetween) than a total circumferential area occupied bythe opening 122.

FIG. 11D depicts the deployment device 100 of FIGS. 11A through 11Cduring removal from the prosthesis 112 through the opening 154. Asillustrated, the flexible support structure 102 can assume a collapsedconfiguration, e.g., which includes at least one bend, fold, or othercollapsed state. The collapsed configuration can allow the flexiblesupport structure 102 to pass through the opening 154 and therebyretreat from the enclosure 124. As with the embodiments of FIGS. 1Athrough 8, removal of the deployment device 100 can result in anenlargement of the enclosure 124, which can be caused by pulling one orboth of the tabs 104 in a direction away from the prosthesis 112. Asnon-limiting examples, the reconfiguration (e.g., in shape, orientation,or both) of the flexible support structure 102 can be caused by pullingone of the tabs 104 in any one of example directions 140 a, 140 b, 140c, or in another direction away from the prosthesis 112.

Still other embodiments are possible. For example, the tab 104 caninclude one or more additional components, such as an insertion device,a positioning device, or another device or component. FIG. 12A depictsthe deployment device 100 according to an additional embodiment of thepresent invention, wherein the tab 104 includes a protruding portion 164and an insertion device 160. For instance, the insertion device 160 canbe an elongate, generally tubular, hollow rod inside which the flexiblesupport structure 102 (and the protruding portion 164) can be movablypositioned. The insertion device 160 can be coupled to or otherwisejoined with the deployment device 100 (e.g., at the tabs 104, on someportion of the flexible support structure, on additional slack thatremains within the insertion device 160, etc.). The insertion device 160can be constructed from metal, plastic, or any other suitable material.

As illustrated in FIG. 12B, the insertion device 160 can be insertedinto the prosthesis 112 through the opening 154, e.g., along with theflexible support structure 102 contained therein but unexposed at anopen distal end 162. Once positioned appropriately (for instance, acrossat least the entire width of the opening 122), the insertion device 160can be removed through the opening 154 so that it is no longerpositioned in the prosthesis 112, thereby enabling the flexible supportstructure 102 to assume a deployed (e.g., generally planar)configuration, as depicted in the example deployed (e.g., generallyplanar) configuration of FIG. 12C. Once the prosthesis 112 is suitablyaffixed or implanted at a target site of an anatomical defect, the tab104 (e.g., the insertion device 160 and/or the protruding portion 164)can be pulled in a direction away from the prosthesis 112, therebyenabling reconfiguration of the flexible prosthesis 102 and removal ofthe deployment device 100.

Alternatively, the insertion device 160 can be unconnected to andinitially separate from the deployment device 100. For example, theinsertion device 160 can be inserted into the prosthesis 112 prior toplacing the deployment device 100 therein. Once the insertion device 160is inserted and properly positioned in the prosthesis 112, a surgeon orother operator handling the deployment device 100 can “feed” thedeployment device 100 through the insertion device 160 such that itmoves through the tubular length of the insertion device 160 and out theopen distal end 162. Simultaneously or subsequently, the insertiondevice 160 can be pulled away and removed from the prosthesis 112,thereby exposing the flexible support structure 102 and enabling it toassume a deployed (e.g., generally planar) configuration. Once preparedfor removal, the protruding portion 164 of the tab 104 can be used tocause the deployment device 100 to reconfigure in order to retreat fromthe enclosure 124 of the implanted prosthesis 112.

Furthermore, the insertion device 160 additionally can serve as a toolfor inserting the prosthesis 112. For example, once the insertion device160 is positioned as depicted in FIG. 12B (e.g., with the flexiblesupport structure 102 contained within the insertion device 160), theprosthesis 112 can be wrapped around the insertion device 160. Next, theinsertion device 160, along with the prosthesis 112 wrapped therearound,can be inserted into a body at the target site of the anatomical defect.The prosthesis 112 can be allowed to unroll at the target site, and theinsertion device 160 can be pulled away and removed from the prosthesis112, as depicted in FIG. 12C. In some instances, the insertion device160 can remain in the prosthesis 112 at a perimeter of the enclosure 124while the flexible support structure 102 is deployed. This can bebeneficial in ensuring that the flexible support structure 102 fullydeploys in the prosthesis 112.

Accordingly, for these and other embodiments, the flexible supportstructure 102 further can be sufficiently flexible to assume a collapsedconfiguration sufficient for insertion into the body, e.g., with aninsertion, positioning, or other device.

Furthermore, prostheses and deployment devices, according to embodimentsdescribed and depicted herein, can be packaged and sold in kits. Forexample, kits according to some embodiments of the present inventioneach include one or more deployment devices each being inserted into aprosthesis, e.g., in a rolled or other collapsed configuration, oralternatively in a non-collapsed configuration. In other embodiments ofthe present invention, the kits each can include one or more prosthesesand one or more deployment devices that are not inserted into the one ormore prostheses. For example, such a kit 200 is depicted in FIG. 13. Oneof skill in the art will appreciate that there is no limit on the numberof deployment devices 100 and prostheses 112 that are included in thekit 200. For example, the kit 200 can include a first prosthesis 112 ₁,a second prosthesis 112 ₂, up through an nth prosthesis 112 _(n).Similarly, the kit 200 can include a first deployment device 100 ₁, asecond deployment device 1002, up through an nth deployment device 100_(n). The number of prostheses 112 and deployment devices 100 in the kit200 need not be the same. Furthermore, as alternatives, one or both ofthe prosthesis 112 and the deployment device 102 can be packaged and/orsold separately.

Still other embodiments are possible. FIG. 14 depicts an exampleembodiment of a flexible support structure 102 having a serpentineconfiguration. In particular, the flexible support structure 102includes a serpentine edge 172. A “serpentine edge” herein refers to anarrangement of one or more connected edges that extend from an inner(e.g., central) portion of the flexible support structure 102 to one ormore points on the perimeter of the flexible support structure 102. Inillustrative embodiments, the serpentine edge 172 sweeps out a full 360degrees (e.g., by making at least one complete revolution). Furthermore,in illustrative embodiments, the serpentine edge 172 is a spiral edge.As depicted in FIG. 14, the serpentine edge 172 includes an inner endproximate to the center of the flexible support structure 102 and anouter end at a point on the perimeter of the flexible support structure102. Abutting portions of the flexible support structure 102 along theserpentine edge 172 are discontinuous and physically unconnected alongthe serpentine edge 172. The discontinuous and physically unconnectedportions formed by the serpentine edge 172 are held in place by aremovable connector piece.

For example, FIG. 15 depicts an illustrative embodiment of such aremovable connector piece 168, which includes four rectangular elongateportions 170 adjoined at a central portion 171 and forming a cross-likeshape. In some embodiments, the removable connector piece 168 includes aprotective film that is not easily penetrated by tacks or sutures. Forexample, the protective film can be a component that is independent fromthe removable connector piece 168 and that slips over the removableconnector piece 168 prior to insertion into the flexible supportstructure 102. This can be useful in providing protective measures thataid in preventing unintentional fixation by a surgeon at undesirablepositions (e.g., on the deployment device 100 and/or a patient'sviscera). The protective film can include two slits that are aligned(positioned in-line) with the strap slots 174. Accordingly, theprotective film can be positioned over (e.g., slid over) the strap 176and the additional strap 182 such that both the strap 176 and theadditional strap 182 pass through the protective film.

Continuing with the example embodiment of FIG. 14, the flexible supportstructure 102 can include a plurality of slits 166 (e.g., relativelythin openings) in its surface for receiving the removable connectorpiece 168, e.g., in a threaded (repeating over-and-under) fashion.Accordingly, the slits 166 can be arranged in a straight line asdepicted in FIG. 14, so as to ease in the removal of the removableconnector piece 168 therefrom.

One of skill in the art will appreciate that other receiving mechanismsbesides the slits 166 can be included for receiving (e.g., releasably)the removable connector piece 168. For example, as additions oralternatives to the slits 166, the flexible support structure 102 caninclude loops, straps, large openings, and any other suitable receivingmechanism. Furthermore, the slits 166 or alternative receivingmechanisms can be arranged in other shapes and configurations besidesthe straight lines depicted in FIG. 14. In some embodiments, only onesuch slit 166 or receiving mechanism is included, rather than theplurality depicted in FIG. 14. Furthermore, one of skill in the art willreadily appreciate that other mechanisms having different shapes can beincluded as alternatives or additions to the elongate portions 170.Additionally, the number of elongate portions 170 or equivalentmechanisms included in the removable connector piece 168 can bedifferent from the embodiment depicted in FIG. 15. For example, theremovable connector piece 168 can include one, two, three, four, five,six, etc. appendages or distinctly shaped portions. One of skill in theart will appreciate yet other alternatives upon reading the presentspecification. The present invention is not limited to the illustrativeexamples provided herein. All alternatives and modifications arecontemplated within the scope of the present invention.

The flexible support structure 102 and the removable connector piece 168each can include one or more strap slots 174 for enabling one or morestrap components to fit therethrough. In the illustrative embodiment ofFIG. 14, each of the flexible support structure 102 and the removableconnector piece 168 includes two such strap slots 174. However, more orless strap slots 174 can be included therein. The strap slots 174 can beany suitable openings sized to receive one or more straps. The strapslots 174 can be positioned on both the flexible support structure 102and the removable connector piece 168 such that placing the removableconnector piece 168 atop the flexible support structure 102 and aligningthe center points of the removable connector piece 168 and the flexiblesupport structure 102 also results in the strap slots 174 being aligned,e.g., to form a through-opening. Accordingly, in this manner, the strapslots 174 on the flexible support structure 102 can have the samepositions on the flexible support structure 102 as on the strap slots174 on the removable connector piece 168.

FIGS. 16A and 16B depict a top view and a bottom view, respectively, ofthe removable connector piece 168 of FIG. 15 threaded in the slits 166of the flexible support structure 102 of FIG. 14. As depicted, theelongate portions 170 pass successively through the slits 166, therebyforming in an alternating pattern of visibility on each side of theflexible support structure 102. The removable connector piece 168 has astiffness that is sufficient to maintain the positions of abuttingportions of the flexible support structure 102 along the serpentine edge172 (e.g., prevent folding and overlap of the abutting portions),thereby structurally reinforcing the flexible support structure 102 andproviding it with suitable deployment characteristics. In theillustrative embodiment of FIG. 15, the removable connector piece 168further is sufficiently flexible to allow the removable connector piece168 to bend so that it may be received by the flexible support structure102 and removed therefrom.

In addition, FIGS. 16A and 16B illustrative that the strap slots 174 ofthe flexible support structure 102 and of the removable connector piece168 align when the removable connector piece 168 is received by theflexible support structure 102. Said differently, the strap slots 174 ofthe flexible support structure 102 overlap with the strap slots 174 ofthe removable connector piece 168. Thus, one or more straps are enabledto easily pass through the overlapping strap slots 174 of FIGS. 16A and16B, thereby passing through both the flexible support structure 102 andthe removable connector piece 168.

For example, FIG. 17 depicts a strap 176 that includes two strapappendages 178 and a strap base 180. The strap appendages 178 are sizedto fit through the strap slots 174 of both the flexible supportstructure 102 and the removable connector piece 168. When received bythe strap slots 174 of the flexible support structure 102 and theremovable connector piece 168, the strap base 180 sits below a centralportion of the flexible support structure 102. Accordingly, the strapappendages 178 are included to facilitate removal of the flexiblesupport structure 102 from a prosthesis, such as the prosthesis 112 ofFIG. 2A through 2C. Similar to the methods described previously herein,pulling the strap 176 (e.g., pulling the strap appendages 178) in adirection away from the prosthesis 112 causes the strap base 180 toproduce an upward force against the center of the flexible supportstructure 102, which causes the flexible support structure 102 to beremoved by contacting the mouth of the opening 122 and reconfiguringinto a shape enabling its passage through the opening 122.

For the flexible support structure 102 to reconfigure into a shapesuitable for passage through the opening 122 of the prosthesis 112, theremovable connector piece 168 first must be removed. Accordingly, inaddition to the strap 176, one or more additional straps can be coupledto or received by the removable connector piece 168 to facilitateremoval of the removable connector piece 168. For example, FIG. 18depicts an additional strap 182 that includes a continuous elongatemember (e.g., formed of a single piece of material) passing through afirst strap slot 174, passing below the central portion 171 of theremovable connector piece 168, and passing through a second strap slot174. For embodiments such as that depicted in FIG. 18 where theadditional strap 182 passes through the strap slots 174 of the removableconnector piece 168, the additional strap 182 does not pass through thestrap slots 174 of the flexible support structure 102. Said differently,the additional strap 182 for enabling the removable connector piece 168to be removed from the flexible support structure 102 is not received bythe flexible support structure 102. Accordingly, gripping the additionalstrap 182 on each end and pulling upward causes the removable connectorpiece 168 to retreat from the slits 166 and bend in manner enabling itsremoval from the flexible support structure 102.

The task of removing the removable connector piece 168 is performedwithout causing the flexible support structure 102 to be removed fromthe prosthesis 112. This is due to the removable connector piece 168being provided with a suitable elasticity and flexibility and the factthat the additional strap 182 is not received by the flexible supportstructure 102. In addition, the removable connector piece 168 and theflexible support structure 102 each can be constructed from a materialhaving a low coefficient of friction. For example, in some embodiments,the removable connector piece 168 and the flexible support structure 102both are constructed from extruded polyester, polyethylene, orpolypropylene, e.g., with smooth surface finishes.

The portion of the additional strap 182 of FIG. 18 passing beneath thecentral portion 171 of the removable connector piece 168 can be affixed(e.g., with adhesive, stitching, etc.) to the underside of the removableconnector piece 168. Alternatively, the additional strap 182 can beslidable through the strap slots 174 of the removable connector piece168. In alternative embodiments, the additional strap 182 is notadjoined to the removable connector piece 168 via the strap slots 174and does not pass through the strap slot 174. Instead, in suchalternative embodiments, the removable connector piece 168 can beaffixed (e.g., as two separate strap appendages) to the upward-facingsurface of the removable connector piece 168. In yet another embodiment,the additional strap 182 includes a single strap appendage adjoined withthe removable connector piece at its center. One of skill in the artwill appreciate a wide variety of other suitable ways and positions atwhich to adjoin the additional strap 182 with the removable connectorpiece 168. The present invention is not limited to the illustrativeexamples described herein. Rather, all such alternatives andmodifications are contemplated as within the scope of the presentinvention.

FIGS. 19A and 19B depict a perspective view and a bottom view,respectively, of the deployment device 100 including the componentsdepicted in FIGS. 14 through 18. Specifically, the deployment device 100of FIGS. 19A and 19B includes: (a) the flexible support structure 102 ofFIG. 14, (b) the removable connector piece 168 of FIG. 15 threadedthrough the slits (as depicted in FIGS. 16A and 16B), (c) the strap 176of FIG. 17 received through the strap slots 174 of both the flexiblesupport structure 102 and the removable connector piece 168, and (d) theadditional strap 182 of FIG. 18 received by the strap slots 174 of theremovable connector piece 168 (and not received by the strap slots 174of the flexible support structure 102). In such embodiments, the strap176 forms the tab 104. Accordingly, the tab 104 is received by theflexible support structure 102 rather than affixed to the flexiblesupport structure 102. However, it should be appreciated that the strap176 alternative can be affixed to the flexible support structure 102 inthe example embodiment of FIGS. 19A and 19B.

FIG. 20 depicts a perspective view of the deployment device 100 of FIGS.19A and 19B situated in the prosthesis 112 of FIGS. 2A through 2C. Forpurposes of clarity, the serpentine separation line 173 is notillustrated. In the embodiment of FIG. 20, as with previous illustrativeembodiments of the present invention, the flexible support structure 102of the deployment device 100 extends to a perimeter of the prosthesis112, allowing the flexible support structure 102 to sit securely withinthe prosthesis 112 without any need for an attachment mechanism, such asadhesive or stitching. For example, as depicted in FIG. 20, the flexiblesupport structure 102 can extend substantially to the outer perimeter118 of the first layer 114 and/or the outer perimeter 120 of the secondlayer 116. In some embodiments, the flexible support structure 102extends to and is in contact with a radially outermost surface 125 ofthe enclosure 124 when the flexible support structure 102 is in adeployed (e.g., generally planar) configuration, as depicted anddescribed previously herein with reference to FIG. 2C. The deploymentdevice 100 of FIG. 20 is removed from the prosthesis 112 in a stepwisefashion, first by pulling on the additional strap 182 to remove theremovable connector piece 168, and then by pulling on the strap 176(forming the tab 104) to remove the flexible support structure 102.

As can be seen from FIG. 20, the additional strap 182 is positionedwithin the strap 176. Thus, a surgeon is enabled to remove the removableconnector piece 168 by pulling upward on the additional strap 182. Thesurgeon further is enabled to remove the flexible support structure 102by pulling upward on the strap 176. In addition to allowing the surgeonto remove the flexible support structure 102, the strap 176 also can beused to assist the surgeon in positioning the prosthesis 112. Forexample, in the system depicted in FIG. 20, manipulating the strap 176prior to release of the removable connector piece 168 from the flexiblesupport structure 102 causes the flexible support structure 102 and theprosthesis 112 to move together. Thus, the strap 176 can provideadditional handling assistance to the surgeon during use of thedeployment device 100.

In some embodiments, the removable connector piece 168 is not included.For example, FIG. 21 depicts an additional embodiment of the deploymentdevice 100 in which the flexible support structure 102 include aserpentine separation line 173. A “serpentine separation line” hereinrefers to an arrangement of one or more connected separation lines thatextend from an inner (e.g., central) portion of the flexible supportstructure 102 to one or more points on the perimeter of the flexiblesupport structure 102. The term “serpentine” can include straight lines,jagged lines, curved lines, and the like. As utilized herein, a“separation line” generally refers to any straight, curved, jagged, etc.pathway situated in one or more materials that is adapted to be torn(e.g., without separating abutting portions in the one or more materialsthat are away from the separation line). A separation line can extendacross one material or multiple different materials and can extendacross one or multiple types of objects. In illustrative embodiments,the serpentine separation line 173 travels some angular distancerelative to its inner endpoint (e.g., does not follow a straight line).In further illustrative embodiments, the serpentine separation line 173travels an angular distance of at least 360 degrees (e.g., by making atleast one complete revolution). Furthermore, in illustrativeembodiments, the serpentine separation line 173 is a spiral separationline. The serpentine separation line 173 can include and be implementedby a series of through-holes, a thin or weaker material, or any othertype of separation line. One of skill in the art will appreciate yetother materials, implementations, shapes, and the like for theserpentine separation line 173. All such alternatives are contemplatedwithin the scope of the present invention.

In the example embodiment of FIG. 21A, the serpentine separation line173 is formed of a series of through-holes 184 extending through anentirety of the flexible support structure. Accordingly, upon separatingthe series of through-holes 184 along the serpentine separation line173, portions of the flexible support structure 102 abutting along theserpentine separation line 173 are released and a serpentine edge 172 isformed (see FIG. 21B, see also FIG. 25B). FIG. 22 depicts a close-upview of the deployment device 100 at a central portion thereof. Theseries of through-holes 184 (represented by a dashed line) are sized andspaced to maintain some limited structural reinforcement betweenabutting portions along the serpentine separation line 173 and create anearly-contiguous surface with minimal void space, but are also designedto create a separation path, e.g., in response to a user tugging orpulling up on the strap 176. For example, the serpentine separation line173 can be constructed by forming a series of perforations in theflexible support structure 102 in a serpentine pattern. Accordingly, theseries of through-holes 184 and the serpentine separation line 173extend from a central portion of the flexible support structure 102 to apoint on a perimeter of the flexible support structure 102. As with theserpentine edge 172 (which is formed by separating the serpentineseparation line 173), the serpentine separation line 173 includes aninner end proximate to the center of the flexible support structure 102and an outer end at a position on the perimeter of the flexible supportstructure 102.

Furthermore, the deployment device 100 can include a stress relief hole186. The stress relief hole 186 is a through-hole disposed at theinnermost end of the serpentine separation line 173 (e.g., the startpoint for forming a separation in the serpentine separation line 173),as depicted in the example embodiment of FIG. 23. In the exampleembodiment of FIG. 23, the stress relief hole 186 is generally circularand is situated near a center of the flexible support structure 102.Functionally, the stress relief hole 186 is a hole situated at thebeginning of the serpentine separation line 173 to effectivelydistribute the stress in this region and thereby reduce the likelihoodof propagation of unintended separations in the flexible supportstructure 102 at non-perforated positions away from the serpentineseparation line 173 (e.g., as might be caused by a sharp pull on thestrap 176). In this manner, the stress relief hole 186 can aid ininitiating a separation in the serpentine separation line 173 based on apulling force on the strap 176 serpentine. As a result, a sharp pull andsubsequent steady pull force on the strap 176 causes the series ofthrough-holes 184 to separation along the serpentine separation line173. In this manner, the serpentine edge 172 is formed and abuttingportions along the serpentine separation line 173 become unconnected toone another, enabling them to collapse (i.e., fold and deform) duringremoval of the deployment device 100 from the prosthesis 112 (e.g., theprosthesis of FIGS. 2A through 2C).

In the example embodiment of FIG. 23, the strap 176 used for separatingalong the series of through-holes 184 in the serpentine edge 172 can bea single continuous elongate member (e.g., formed of a single piece ofmaterial) that passes in one of the strap slots 174, beneath a centralportion of the flexible support structure 102, and through another ofthe strap slots 174. As with all other straps provided herein, the strap176 generally can be flexible or rigid (e.g., allowing it to be used asa positioning device or handling device during deployment and/orfixation).

Alternatively or additionally to providing the series of through-holes184 between abutting portions of the flexible support structure 102along the serpentine separation line 173, a relatively weaker (e.g.,relatively thinner) strip of material can be disposed continuously in aserpentine along the flexible support structure 102 for forming theserpentine separation line 173. For example, FIG. 24 depicts one exampleembodiment of such a continuous strip 188 of material forming theserpentine separation line 173. The continuous strip 188 of material canbe weaker (e.g., thinner) relative to a remainder of the flexiblesupport structure 102. For example, the continuous strip 188 of materialalong the serpentine separation line 173 can be formed by directing alaser (e.g., at a particular power level) at the flexible supportstructure 102 and moving the laser in a serpentine path (or moving theflexible support structure 102 in a serpentine path relative to thelaser), thereby thinning the material of the flexible support structure102 at points contacted by the laser (a technique commonly referred toas “kiss cutting”). The depth of the cut can be selected to ensure easyseparation mechanics along the serpentine separation line 173 as wouldbe appreciated by one of skill in the art upon reading the presentspecification, e.g., based on material properties of the material beingused (density, etc.), the size of the material (thickness, etc.), andthe like. In addition, laser cuts can be implemented in such a way thatis optimized to be thick enough to resist fracture duringcompression/folding of the flexible support structure 102, yet thinenough to enable easy separation/removal along the serpentine separationline 173. Alternatively to laser cutting, the continuous strip 188 ofmaterial can be formed by “kiss cutting” sheet stock with a steel ruledie, as would be appreciated by one of skill in the art. Any othersuitable methods of manufacturing the continuous strip 188 of materialalso may be used, such as micro-molding, injection molding, and otheralternative manufacturing methods.

In some embodiments, the kiss cuts can be performed at varyingthicknesses, such that some regions of the serpentine separation line173 are more difficult to separation than other regions. For example, byusing a more shallow kiss cut to form the serpentine separation line 173at a central portion of the flexible support structure 102, theserpentine separation line 173 can be sufficiently strong and durable towithstand use of the straps 178 as rigid handles for intraoperativepositioning and maneuvering of the prosthesis 112. Additionally, formingthe serpentine separation line 173 of a deeper kiss cut at outerportions of the flexible support structure 102 allows the serpentineseparation line 173 to be more easily torn during removal from theprosthesis 112. In addition, kiss cuts can be implemented in such a waythat is optimized to be thick enough to resist fracture duringcompression/folding of the flexible support structure 102, yet thinenough to enable easy separation/removal along the serpentine separationline 173.

In the example embodiment of the deployment device 100 depicted in FIG.24, the serpentine separation line 173 forms about four and a halfrevolutions. However, it should be understood that more or lessrevolutions can be included based on the intended medical applicationsand the particular implementation of the deployment device 100 (e.g.,based on the size of the deployment device 100, the thickness of theflexible support structure 102, etc.). The particular number ofrevolutions formed by the serpentine separation line 173 can be selectedto ensure that the flexible support structure 102 has a flexibility thatis sufficient to allow the flexible support structure 102 to reconfigureand pass through the opening 122 in the prosthesis 112.

Furthermore, the invention is not limited to any particular value ofdensity, thickness, etc. of the flexible support structure 102. Forexample, the flexible support structure 120 can be constructed of lowdensity polyethylene, low density polypropylene, and the like. Rather, awide variety of combinations of specific materials and structuralproperties (e.g., including number of revolutions of the serpentineseparation line 173) can be selected to provide the flexible supportstructure 102 with a flexibility sufficient to reconfigure and passthrough the opening 122 in the prosthesis 112. FIG. 25A depicts thedeployment device 100 of FIG. 24 situated in the prosthesis 112 of FIGS.2A through 2C. The deployment device 100 is removed by providing a sharppull on the strap 176 to begin separating the continuous strip 188 ofmaterial at the stress relief hole 186, then by steadily pulling on thestrap 176 in an upward direction away from the prosthesis 112 toprogressively separate the remainder of the continuous strip 188 ofmaterial extending out from the stress relief hole 186. In this manner,abutting portions along the continuous strip 188 of material of theflexible support structure 102 become unconnected and are enabled torelease upward so as to assume a reconfigured (e.g., bent, folded,buckled, overlapping, etc.) shape, e.g., resembling a helix or aconventional spiral staircase. The reconfigured shape allows theflexible support structure 102 to pass through the opening 122, whichhas a smaller total circumferential area than the total circumferentialarea of the flexible support structure 102 in the deployed (e.g.,generally planar) state. For example, the flexible support structure 102is depicted in a helix configuration in FIG. 25B. Specifically, FIG. 25Billustrates a perspective view of a surgeon 190 removing the flexiblesupport structure 102 through a hole or defect 192 in an artificialmuscle wall 194. The step shown in FIG. 25B occurs after implanting theprosthesis (not visible in FIG. 25B) through the hole or defect 192 andaffixing it to the artificial muscle wall 194 (e.g., with tacks orsutures). The ability of the flexible support structure 102 toreconfigure into a helix affords the deployment device 100 greatversatility. For example, this feature is particularly advantageous forthe reason that it allows the deployment device 100 to reconfigure in amanner enabling extraction through nearly any size defect or orifice.

It should be noted that the continuous strip 188 that results from theflexible support structure 102 being reconfigured to enable removal ofthe structure can include the continuous strip 188 terminating in a loopor ring configuration. Specifically, referring back to FIG. 21B, theflexible support structure 102 is shown after having been reconfiguredby separating the structure along the serpentine separation line, with aloop or ring 181. As shown and configured, the ring 181 is formed by theouter most perimeter of the original flexible support structure 102. Asthe flexible support structure is removed from the prosthesis, the ring181 is maintained at the end of the elongate continuous strip 188 tosignal to the surgeon that the entire flexible support structure 102 hasbeen removed from the prosthesis (once the surgeon sees the ring 181exiting from the prosthesis). Those of skill in the art will appreciateother ways to provide a signal or indication to the user of the lastremaining portion of the flexible support structure 102 that is removedfrom the prosthesis, including the ring 181 or some other structurevariation, or a color or label indicator, or other visual representationindicating the end of the device.

In some embodiments of the present invention, the flexible supportstructure 102 includes one or more reinforcing lips situated beside(e.g., adjacent to and/or contiguous with) the path of the serpentineseparation line 173. For example, FIGS. 26A, 26B, and 26C depict aperspective view, a side view, and a close-up view, respectively, of across section of two such reinforcing lips 204 a, 204 b that can beformed in the flexible support structure 102. As depicted in FIGS. 26Athrough 26C, the flexible support structure 102 is depicted right-sideup (upright and erect). In the example embodiments of FIGS. 26A through26C, the reinforcing lips 204 a, 204 b are formed on both sides of theserpentine separation line 173. Each reinforcing lip 204 a, 204 b iscontiguous with the serpentine separation line 173 at its respectiveside. The serpentine separation line 173 of the example embodiment ofFIGS. 26A through 26C is defined by a thinner region in the material ofthe flexible support structure 102, e.g., formed as a depression in theflexible support structure 102. Each reinforcing lip 204 a, 204 b formsa slight elevation or wall on one side of the depression forming theserpentine separation line 173. The reinforcing lip 204 a follows alongthe path of the separation line 173 on an inner side of the separationline 173. The reinforcing lip 2046 follows along the path of theseparation line 173 on an outer side of the separation line 173. Inother embodiments, however, the reinforcing lips 204 a, 204 b are notincluded.

In one example embodiment, the flexible support structure 102 of FIGS.26A through 26C is constructed from low-density polyethylene and has athickness of about 0.020 inches, a density of about 0.92 g/cm³, a meltflow index (MFI) of about 1.8 g/10 min, and an Elmendorf separationstrength determined through various mechanical tests, e.g., of about 400g in the machine direction (MD) and of about 280 g in the transversedirection (TD). One of skill in the art will appreciate that thesedimensions and material properties are in no way limiting to the scopeof the present invention. Rather, the dimensions and material propertiesprovided herein are exemplary and described merely for purposes ofillustration. Embodiments of the present invention can assume a widevariety of sizes, dimensions, shapes, material properties, and the like,as would be appreciated by one of skill in the art upon reading thepresent specification. The specific values can be selected based on theintended applications (e.g., the intended target site, the intendedmedical applications, etc.).

FIGS. 27A and 27B further depict the flexible support structure 102 ofFIGS. 26A through 26C from a perspective view and a bottom view,respectively. As can be seen, the serpentine separation line 173 and thereinforcing lips 204 a, 204 b collectively form a serpentine pathextending in revolutions from an inner position on the flexible supportstructure 102 to an outer position of the flexible support structure 102(e.g., on a perimeter thereof).

As described previously herein, the serpentine separation line 173 caninclude multiple regions characterized by different thicknesses. Forexample, FIG. 28 depicts an additional embodiment of the deploymentdevice 100 in which the serpentine line 173 includes an inner portion173 a (indicated in the figure by a green line) and an outer portion 173b (indicated in the figure by a red line). The inner portion 173 a has athickness that is greater than a thickness of the outer portion 173 b,e.g., to promote easier separating/release along the outer portion 173 b(e.g., when a surgeon truly intends to remove the deployment device100), and more difficult separating/release along the inner portion 173a (e.g., to provide greater durability enabling a surgeon to manipulatethe straps 176 as positioning/handling mechanisms). The inner portion ofthe serpentine separation line 173 a and the outer portion of theserpentine separation line 173 b can be continuous with one another, asdepicted in the example embodiment of FIG. 28.

Furthermore, as depicted in FIG. 28, the serpentine separation line 173can be preceded at its innermost end by a serpentine through-cut 196.The serpentine through-cut 196 can be a slit-like or slot-like openingsituated in and extending entirely through the flexible supportstructure 102 (i.e., passing from a top surface of the flexible supportstructure 102 to a bottom surface of the flexible support structure102). The serpentine through-cut 196 can follow a path that forms anextrapolation of the serpentine path followed by the serpentineseparation line 173. Accordingly, including the through-cut 196effectively forms a flap that, when pulled upward, initiates release ofthe serpentine separation line 173. At an innermost end, the serpentinethrough-cut 196 can terminate at the stress relief hole 186. At anoutermost end, the serpentine through-cut 196 can terminate at a gap 202of material on the flexible support structure 102 between the serpentinethrough-cut 196 and the innermost end of the serpentine separation line173. For example, the gap 202 can have a thickness that is substantiallyequal to as the thickness of the majority of the flexible supportstructure 102 (e.g., can have a thickness equal to the thickness ofportions situated between the revolutions of the serpentine separationline 173 with the reinforcing walls 204 a, 204 b).

In the example embodiment of FIG. 28, the strap slots 174 a, 174 b canbe distinguished based on proximity to the serpentine through-cut 196.Accordingly, the ends 177 a, 177 b of the strap 176 similarly can bedistinguished based on which strap slot 174 a, 174 b each passes throughand extends from. In the example embodiment of FIG. 28, by providing theserpentine through-cut 196 in a position displaced from the center ofthe flexible support structure 102, the two strap ends 177 a, 177 b canbe used for different functions by a surgeon during intraoperativehandling and manipulation. The strap end 177 a, being more proximate tothe through-cut 196 and less proximate to the thicker inner portion 173a, will more effectively break the gap 202 of material and initiaterelease of the separation line 173 in response to a moderate tug or pullby the surgeon. Stated differently, tugging upward on the strap end 177a causes the semi-circular flap formed by the through-cut 196 to liftupward and eventually distribute enough tension on the gap 202 toseparation the gap 202 and thereby initiate release of the spiralseparation line 173. On the other hand, the strap end 1776, being lessproximate to the through-cut 196 (i.e, more distal from the through-cut196) and more proximate to the thicker inner portion 173 a, will moreeffectively serve as a positioning tool which can better distributetensile forces due to tugs and pulls without initiating release of theseparation line 173.

It should be noted that the serpentine separation line 173 and theserpentine edge 172 can assume other types of serpentine shapes besidesthe exemplary smoothly curved serpentines and spirals depicted in thefigures. For example, the serpentine separation line 173 and/or theserpentine edge 172 can be shaped as square serpentines/spirals, othershaped serpentines/spirals, or combinations thereof. As yet furtherexamples, FIGS. 29A and 29B depict the flexible support structure 102with alternative serpentine separation lines 173, according toembodiments of the present invention. As depicted in FIGS. 29A and 29B,the serpentine separation line 173 can include a plurality (e.g., two,three, four, five, etc.) of branches 179 that each terminates at one ormore positions on the flexible support structure 102 and which arecontinuous with and connected to one another. As depicted in FIGS. 29Aand 29B, the branches 179 of the serpentine separation line 173 canterminate at a position inward from the perimeter of the flexiblesupport structure 102.

FIG. 30 depicts the strap 176 according a further example embodiment ofthe present invention. As described previously, in such embodimentswhere the strap 176 is included, the strap 176 can form the tab 104. Amedial portion 208 is slightly displaced from the center of the strap176. The medial portion 208 thus divides the strap 176 into a longerappendage 178 a and a shorter appendage 178 b (relative to one another).As depicted in FIG. 30, the strap 176 is depicted in an unassembledform, such that the appendages 178 a, 178 b are aligned along the sameplane. To assemble the strap 176, the appendages 178 a, 178 b are bentat the outer edges of the medial portion 208, such that the appendages178 a, 178 b are erect and upright. A finger support ring 206 is adaptedto receive the finger of a user and is situated at the end 177 a of thelonger appendage 178 a. The base portion 180 is not included in thestrap 176 of the example embodiment of FIG. 30. Each appendage 178 a,178 b includes one or more barb mechanisms 214 extending therefrom that,once slid through the strap slots 174, act as mechanical stops thatprevent the appendages 178 a, 178 b from sliding through the strap slots174 in either direction. A slit 210 is situated in and through the end177 a of the longer appendage 178 a, slightly inward of the fingersupport ring 206. The slit 210 is sized, shaped, and dimensioned toreceive a protuberance 212 formed on the end 177 b of the shorterappendage 178 b. The protuberance 212 is sized, shaped, and dimensionedto pass through the slit 210 and subsequently lock in place by turning.The protuberance 212 is released by turning in the opposite direction tounlock. In illustrative embodiments, the strap 176 is formed ofpolypropylene, PETG (polyethylene terephthalate glycol-modified), or anyother suitable (e.g., medical-grade) material. One of skill in the artwill appreciate a variety of other materials herein that can be used toform the strap 176. All such alternatives and modifications arecontemplated within the scope of the present invention.

FIG. 31A depicts the strap 176 of FIG. 30 coupled to the flexiblesupport structure 102 of the deployment device 100 depicted in FIG. 28.The deployment device 100 is situated within the prosthesis 112 of FIGS.2A through 2C. The longer appendage 178 a is adapted to be affixed tothe flexible support structure 102 on the semi-circular flap formed bythe serpentine through-cut 196. The shorter appendage 178 b is adaptedto be affixed at a location not on the semi-circular flap formed by theserpentine through-cut 196. The medial portion 208 of the strap 176 issituated on top of the flexible support structure 102, such that thebarb mechanisms 214 pass down through the strap slots 174 to fixedlylatch onto the flexible support structure 102. As shown in FIG. 31A, thestrap 176 is in a locked configuration. When in the locked configurationof FIG. 31A, the strap 176 forms and serves as a positioning tool, asdescribed previously herein with reference to FIG. 28. Specifically, dueto the differences in length, the shorter appendage 178 b is taught,whereas the longer appendage 178 a is bent and includes some slack.Thus, forces on the finger support ring 206 are distributed along theshorter appendage 178 b when the strap 176 is in the lockedconfiguration. Given that the appendage 178 b is not affixed on thesemi-circular flap formed by the serpentine through-cut 196, forces onthe finger support ring 206 are distributed more evenly across flexiblesupport structure 102 in a manner that tends to avoid initiating releaseof the serpentine separation line 173 when the strap 176 is in thelocked configuration.

FIG. 31B depicts the strap 176 in an unlocked configuration. In theunlocked configuration, forces on the finger support ring 206 aredistributed along the longer appendage 178 a. Thus, the resultingtensile forces on the flexible support structure 102 are distributed onthe semi-circular flap formed by the serpentine through-cut 196. Thisfocusing of tensile forces on the semi-circular flap formed by theserpentine through-cut 196 enables the semi-circular flap to be liftedin such a way as to separation the gap 202 and initiate separation ofthe serpentine separation line 173. Accordingly, when the strap 176 isin a locked configuration, the strap 176 effectively serves as apositioning device, whereas when the strap 176 is in an unlockedconfiguration, the strap 176 effectively serves as the tab 104 forremoving the deployment device 100 from the prosthesis 112.

Deployment devices 100 according to embodiments of the present inventioncan significantly improve prosthesis deployment for surgeons by easingthe process of positioning a prosthesis during and after implantation.Moreover, deployment devices 100 according to embodiments of the presentinvention can eliminate the requirement for stitches or other fixationapparatuses used to secure a wire frame to a prosthesis. This cansignificantly reduce surgical time and operating room time, whileproviding a significantly easier mechanism for removing the deploymentdevice 100. Rather than cutting or removing stitches at the periphery ofa prosthesis, the deployment device 100 can be easily and immediatelyremoved simply by pulling the tab 104 (e.g., straps, protrudingsegments, and any other tab described herein). As such, embodiments ofthe present invention eliminate risk of harm to a patient caused bycutting devices, etc.

Furthermore, deployment devices 100 utilizing a flexible supportstructure 102 forming a solid sheet or relatively solid sheet ofmaterial provide additional protection to a patient while a surgeon isaffixing the prosthesis with tacks or sutures. The solid sheet layerprevents suture needles or tacks from being improperly placed therein,which helps a surgeon avoid accidental punctures to organs. For example,misplacing suture needles or tacks at an undesirable peripheral positionon the prosthesis could result in a surgeon unintentionally piercing anorgan below the prosthesis 112 that is hidden from view. Certainembodiments of the present invention overcome such risks by providing adeployment device 100 that is to be removed and thus is not to beaffixed to surrounding tissue, etc.

Embodiments as depicted in FIGS. 24 through 31B that include aserpentine separation line 173 (e.g., formed of a continuous strip 188of material) may be particularly beneficial for certain medicalapplication. For example, embodiments having a continuous strip 188 ofmaterial create a surface for fixation guidance that can be wholly andentirely void of any openings or gaps, thereby presenting a surface forfixation guidance that is smooth and continuous prior to separatingalong the serpentine separation line 173. Furthermore, such continuousstrips 188 of material create less risk of material being dispelled fromthe deployment device 100 during or after separating along theseparation line 173. In addition, unlike the series of through-holes184, separating the continuous strips 188 of material does not result insharp or jagged edges being formed that could potentially create scrapesor scratches during removal, which may be beneficial in certainapplications.

In providing a deployment device that is removable, embodiments of thepresent invention achieve a deployment device 100 that can greatlyreduce dangerous post-operative complications and failures of aprosthesis caused by permanent rings or frame members currently used inprior art devices. In embodiments of the present invention, the full andcomplete removal of the deployment device 100 allows the prosthesis tobe placed in the body without any additional rings or frame memberspermanently remaining therein. This creates a smooth surface in theprosthesis, which eliminates undesired surface tensions in theprosthesis that can cause failure and patient discomfort. By having lessforeign material remain in the body, immunological complications can beminimized as well.

Furthermore, the deployment device 100 also functions as a barrier toprevent undesirable contact between the lower layer of mesh orunderlying visceral tissue (e.g., bowel, etc.) and fixation elements(e.g., suture needles, tacks, etc.). The absence of voids across thesmooth contiguous surface of the deployment device 100, which inillustrative embodiments spans across the entire interior of theprosthesis 112, can offer a solution to the potential problem ofinadvertent surgical contact with surrounding tissue during the surgicalprocedure.

Notably, deployment devices 100 according to embodiments of the presentinvention achieve greater cost-effectiveness than existing prosthesisdeployment devices, such as hernia patch deployment devices. Forexample, various component parts (e.g., including the flexible supportstructure 102) can be manufactured by cutting from a flat sheet ofmaterial. Accordingly, embodiments of the present invention enablegreater manufacturing simplicity, thereby achieving improved costsavings. One of skill in the art will appreciate yet additional benefitsnot specifically mentioned herein upon reading the presentspecification.

Numerous modifications and alternative embodiments of the presentinvention will be apparent to those skilled in the art in view of theforegoing description. Accordingly, this description is to be construedas illustrative only and is for the purpose of teaching those skilled inthe art the best mode for carrying out the present invention. Details ofthe structure may vary substantially without departing from the spiritof the present invention, and exclusive use of all modifications thatcome within the scope of the appended claims is reserved. Within thisspecification embodiments have been described in a way which enables aclear and concise specification to be written, but it is intended andwill be appreciated that embodiments may be variously combined orseparated without parting from the invention. It is intended that thepresent invention be limited only to the extent required by the appendedclaims and the applicable rules of law.

It is also to be understood that the following claims are to cover allgeneric and specific features of the invention described herein, and allstatements of the scope of the invention which, as a matter of language,might be said to fall therebetween.

1. A deployment device, comprising: a flexible support structureconfigured in generally planar form having a total circumferential areain a deployed configuration, and configured to independently apply aradial deployment force to achieve the deployed configuration; aseparation line in the flexible support structure extending in agenerally serpentine shape from a central portion of the flexiblesupport structure to a perimeter of the flexible support structure; athrough-cut disposed at and an innermost end of the separation line atthe central portion of the flexible support structure; a first strapcoupled with the flexible support structure in the central portion andproximal the through-cut; a second strap coupled with the flexiblesupport structure in the central portion and more distal from thethrough-cut than the first strap; wherein a pulling force applied to thefirst strap initiates separation along the separation line beginning atthe through-cut; wherein the first strap and the second strap areadapted to lock together at locations distal from the flexible supportstructure, and when in a locked configuration form a positioning toolfor positioning the device, and when in an unlocked configuration form aremoval tool enable the pulling force applied to the first strap toinitiate the separation along the separation line beginning at thethrough-cut; and wherein the second strap is configured and positionedin such a way that a pulling force applied to the second strap does notinitiate separation along the separation line beginning at thethrough-cut, thereby making the second strap a useful positioning toolfor positioning the flexible support structure.
 2. The device of claim1, wherein the flexible support structure is configured to be removedthrough an opening in a prosthesis having a total circumferential areathat is less than the total circumferential area occupied by theflexible support structure when in the deployed configuration. 3-4.(canceled)
 5. The device of claim 1, wherein the deployment devicecomprises the separation line, and wherein the separation line comprisesa plurality of through-holes.
 6. The device of claim 1, wherein thedeployment device comprises the separation line, and wherein theseparation line comprises a continuous strip of material.
 7. The deviceof claim 1, wherein the deployment device comprises the separation linein the flexible support structure.
 8. (canceled)
 9. The device of claim1, wherein the first strap and the second strap are coupled together atends proximal the flexible support structure.
 10. The device of claim 1,wherein the first strap and the second strap are a continuous elongatestrap. 11-12. (canceled)
 13. The device of claim 1, wherein the totalcircumferential area of the flexible support structure configured ingenerally planar form in the deployed configuration is sized anddimensioned to fit within and completely expand and deploy a prosthesisinto which the device is positioned, the prosthesis comprising a toplayer and a bottom layer coupled together and forming an enclosuretherebetween into which the device is configured for placement.
 14. Thedevice of claim 1, wherein separation along the separation lineterminates at a ring configuration formed by the outer perimeter of theflexible support structure.
 15. (canceled)
 16. A system, comprising: aprosthesis comprising a top layer and a bottom layer coupled togetherand forming an enclosure therebetween, the top layer having an apertureopening to the enclosure, wherein a circumferential area of the apertureis less than a circumferential area of the top layer in which theaperture is disposed; and a deployment device removably disposed withinthe enclosure, the deployment device comprising: a flexible supportstructure configured in generally planar form having a totalcircumferential area in a deployed configuration, and configured toindependently apply a radial deployment force to achieve the deployedconfiguration when positioned within the enclosure of the prosthesis; aseparation line in the flexible support structure extending in agenerally serpentine shape from a central portion of the flexiblesupport structure to a perimeter of the flexible support structure; afirst strap coupled with the flexible support structure in the centralportion extending through the aperture and external to the prosthesis; asecond strap coupled with the flexible support structure in the centralportion extending through the aperture and external to the prosthesis;wherein a pulling force applied to the first strap initiates separationalong the separation line; wherein the second strap is positioned insuch a way that a pulling force applied to the second strap does notinitiate separation along the separation line; wherein the first strapand the second strap are adapted to assume a locked configurationforming a positioning tool and an unlocked configuration forming adeployment device removal tool; and, wherein if a pulling force isapplied to the first strap, separation occurs along the separation linethe flexible support structure reconfigures from the generally planarform to an elongate continuous strip and continued pulling force causesthe elongate continuous strip to pass through the aperture in such a waythat the flexible support structure is ultimately removed from theprosthesis.
 17. The system of claim 16, further comprising a through-cutdisposed at and an innermost end of the separation line at the centralportion of the flexible support structure.
 18. The system of claim 17,wherein the first strap is disposed proximal the through-cut.
 19. Thesystem of claim 18, wherein the second strap is disposed more distalfrom the through-cut than the first strap.
 20. The system of claim 16,wherein portions of the flexible support structure along the separationline are coupled together prior to removal and are configured toseparate for removal of the deployment device from the prosthesis. 21.The system of claim 16, wherein the deployment device comprises theseparation line, and wherein the separation line comprises a pluralityof through-holes or a continuous strip of material.
 22. The system ofclaim 16, wherein the deployment device further comprises a stressrelief hole or opening situated in and through the flexible supportstructure proximate to an inner end of the separation line. 23-24.(canceled)
 25. The system of claim 16, wherein the first strap and thesecond strap are coupled together at ends proximal the flexible supportstructure.
 26. The system of claim 16, wherein the first strap and thesecond strap are a continuous elongate strap.
 27. The system of claim16, wherein the flexible support structure has an elasticity thatgenerates a force sufficient to cause the prosthesis to assume adeployed configuration from a non-deployed configuration.
 28. The systemof claim 16, wherein the total circumferential area of the flexiblesupport structure configured in generally planar form in the deployedconfiguration is sized and dimensioned in such a way that the structurefits within and completely expands and deploys the prosthesis.
 29. Thesystem of claim 16, wherein separation along the separation lineterminates at a ring configuration formed by the outer perimeter of theflexible support structure. 30-70. (canceled)